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Warning letter fda 2020. WARNING LETTER CMS # 596529 January 17, 2020 Dear Mr.
- Warning letter fda 2020. Aug 4, 2025 · USFDA Warning Letters: An Analysis of Compliance in Over-the-Counter Drug Products (2020–2024) Research Published: 04 August 2025 Volume 20, article number 159, (2025) Cite this article Download PDF Pujita Konda, Sravani yerram, Mohammad Nuwaid Khader, Ramesh Joga, Muhammad NIZAM V P, Mahesh Girhe, Ajmal C S & Saurabh Srivastava 127 Accesses Jan 28, 2025 · Details on medical device warning letters To fully understand FDA’s concerns, we need to look beyond the primary issue, as most warning letters include multiple areas of concern. Jun 12, 2025 · In a June 10, 2025 update, FDA posted seven updated Warning Letters, issued between the beginning of 2025 and the present, to its online database, which stores more than 3400 such letters dating back to 2020 (1). According to FDA, the now-flagged Instagram In July 2020, FDA issued seven warning letters to companies that sell or distribute unauthorized e-liquid products targeted to youth or likely to promote use by youth. Feb 22, 2023 · The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 320-20-44 dated August 20, 2020. You may be surprised at some of them. March 26, 2020 WARNING LETTER Dear Dr. WARNING LETTER WL 594867 Dear Mr. WARNING LETTER Revival Products, Inc. , located at 311 S Wacker Drive, Suite 4100, Chicago, IL 60606-6604 on Compounding Pharmacy/Adulterated Drug ProductsSeptember 17, 2020 Case #: 610545 WARNING LETTER Dear Mr. 1% of all warning letters in 2020. Food and Drug Administration (FDA) have sent warning letters to seven companies allegedly selling unapproved products that may violate federal law by making deceptive or scientifically unsupported claims about their ability to treat coronavirus (COVID-19). MARCS-CMS 698214 — December 18, 2024 Jun 10, 2025 · OPDP notes that the Warning Letter dated August 31, 2020, sent to Sprout addressed presentations for Addyi with certain similarities to the post addressed in this letter. Results: Poor compliance to CGMP and misbranding were the most common reasons for the warning letters. Torfi, During an inspection of your firm Invitrx Therapeutics, Inc. For all FDA Warning Letters, click here. Jan 26, 2021 · We examined the seven advertising and promotion letters issued by OPDP, OPEQ, and OMDRHO, and analyzed the most frequently cited allegations. Jul 11, 2025 · As of July 2025, the U. , related to an FDA Warning Letter to Question Nutrition, LLC dated July 29, 2015 6 days ago · WARNING LETTER CMS # 709948 September 9, 2025 Dear Mr. Food and Drug Administration (FDA) has issued over 3,400 warning letters, with the most recent 100 painting a vivid picture of persistent industry-wide compliance gaps. , located at 20503 Crescent Bay Drive, Lake Forest, CA CGMP DeviationsMay 14, 2020 20-603610 WARNING LETTER Dear Mr. Deas, Jr. Noble: The United States Food and Drug Administration (FDA) conducted an inspection of your firm’s FDA issued 22 warning letters to online & brick-and-mortar e-cigarette product retailers/manufacturers across the country who sell flavored, cartridge-based electronic nicotine delivery system Home Inspections, Compliance, Enforcement, and Criminal Investigations Compliance Actions and Activities Warning Letters Mercola. The Food and Drug Administration (FDA) plays a pivotal role in this oversight in the United States, particularly through Good Manufacturing Practices (GMPs). Jakobs: The United States Food and Drug Administration (FDA) conducted the following inspections of your firm’s medical device facilities WARNING LETTER CMS # 599789 July 23, 2020 Dear Mr. Food and Drug Administration (FDA) reviewed your website at the Internet Home Inspections, Compliance, Enforcement, and Criminal Investigations Compliance Actions and Activities Warning Letters Wintac Limited - 606700 - 08/13/2020 WARNING LETTER Centurion Medical Products Corporation MARCS-CMS 598837 — June 11, 2020 Home Inspections, Compliance, Enforcement, and Criminal Investigations Compliance Actions and Activities Warning Letters Luminex Corporation - 606267 - 06/26/2020 This warning letter summarizes significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. Common findings violate principles of ALCOA+, 21 CFR Part 11, and the FDA’s data integrity guidance document. Mar 17, 2020 · Home Inspections, Compliance, Enforcement, and Criminal Investigations Compliance Actions and Activities Warning Letters Cipla Limited - 597511 - 02/25/2020 This warning letter summarizes significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. The warning letters are the first issued by the agencies alleging unapproved and/or unsupported Jun 11, 2025 · The US Food and Drug Administration (FDA) has warned Sprout Pharmaceuticals for the second time concerning its promotion of its hypoactive sexual desire disorder (HSDD) drug Addyi. Food and Drug Administration (FDA) issued warning letters to seven companies whose products claim to cure, … limiting their consumption of alcoholic beverages. Food and Drug Administration (“FDA”) Office of Prescription Drug Promotion (“OPDP”) posted a warning letter (the “Letter”) [1], issued on May 29, 2025, to Sprout Pharmaceuticals, Inc. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter [CMS #557903], dated November 9, 2018, and subsequent Send your electronic reply to orapharm1_responses@fda. Samchundang Pharm Co. 9% in 2019 to 33% in 2020. February 26, 2020 Warning Letter #OBPO 20-598552 Dear Dr. This alert summarizes the letters and other enforcement trends. WARNING LETTER The Elderberry Co. Nov 24, 2020 · Warning Letters Aurolife Pharma, LLC - 607087 - 10/16/2020 Warning Letters WARNING LETTER Aurolife Pharma, LLC MARCS-CMS 607087 — October 16, 2020 Delivery Method: Certified Mail Product: Drugs WARNING LETTER CMS # 611243 November 24, 2020 Dear Mr. Despite stringent internal controls and monitoring systems Mar 24, 2020 · WARNING LETTER CMS # 598233 February 19, 2020 Dear Mr. Jul 8, 2025 · The FDA issues warning letters to clinical investigators, sponsors, and institutional review boards for violations in conducting clinical trials. Food and Drug Administration has issued warning letters to three companies for marketing adulterated and misbranded COVID-19 antibody tests. 351, Hyoryeong-ro Seocho-gu Seoul 06643 South Korea Issuing Office: Center for Drug Evaluation and Research | CDER United States Warning Letter 320-20-35 May 13, 2020 The FDA and the FTC issued warning letters to seven companies for selling fraudulent COVID-19 products. Feb 6, 2023 · Learn the key pharmaceutical warning letter and inspection observation trends throughout 2022 along with resources and expert advice for quality leaders. - 607305 - 10/20/2020 Jun 23, 2020 · In 2020 thus far, numerous warning letters have been issued from the FDA citing data integrity violations. Food and Drug Administration (FDA) investigator WARNING LETTER CPAPNEA Medical Supply MARCS-CMS 592737 — January 22, 2020 Aug 3, 2021 · Home Inspections, Compliance, Enforcement, and Criminal Investigations Compliance Actions and Activities Warning Letters Syntec Pharma Corp - 612765 - 07/06/2021 Home Inspections, Compliance, Enforcement, and Criminal Investigations Compliance Actions and Activities Warning Letters HNC Products Inc. Costilla: The United States Food and Drug Administration (FDA) inspected your facility located at 1420 Decision St. Hirsch: The United States Food and Drug Administration (FDA) inspected your ready-to-eat (RTE) seafood processing facility, Fuji Food The Federal Trade Commission and U. COVID-19 related violations accounted for 42. MARCS-CMS 617539 — December 09, 2021 WARNING LETTER March 16, 2020 Warning Letter #OBPO 20-581182 Dear Mr. Spanning pharmaceuticals, medical devices, biologics, human and animal food, tobacco, and online marketplaces, these letters underscore a tightening regulatory landscape and a renewed urgency for Methods: Warning letters issued from the time period 2010 to 2020 were obtained from the FDA website, and information about date of issuance, company, and type of violations was extracted for the study. Flaharty, PharmD New Drug/MisbrandedWL 607630 WARNING LETTER Dear Mr. WARNING LETTER Date: September 1, 2020 RE: Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) Jan 14, 2025 · WARNING LETTER Hologic, Inc. CGMP/QSR/Medical Devices/AdulteratedWARNING LETTER CMS # 598171 February 12, 2020 Dear Mr. The agency also sent a warning letter to a company for conducting a clinical investigation without submitting an investigational new drug application (IND). This warning letter summarizes significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. MARCS-CMS 606909 — October 15, 2020 Delivery Method: UPS Product: Drugs Recipient: President/Co-Chief Executive Officer Jan 14, 2025 · Home Inspections, Compliance, Enforcement, and Criminal Investigations Compliance Actions and Activities Warning Letters Xoran Technologies, LLC - 694229 - 12/09/2024 Home Inspections, Compliance, Enforcement, and Criminal Investigations Compliance Actions and Activities Warning Letters Allergan - 607690 - 05/14/2020 The FDA office that issued the Warning Letter will issue the close-out letter, and that office may be contacted for information on a particular Warning Letter or close-out letter. WARNING LETTER CMS # 677524 March 18, 2024 Dear Mr. Glenn Jun 16, 2020 · WARNING LETTER CMS #606982 June 8, 2020 Dear Mr. Warning letters issued from the time period 2010 to 2020 were obtained from the FDA website, and information about date of issuance, company, and type of violations was extracted for the study. Zwischenberger: This Warning Letter is to inform you of objectionable conditions observed during the Food and Drug Administration (FDA) inspection conducted Federal Trade Commission WARNING LETTER Date: October 23, 2020 RE: Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) Jul 3, 2018 · … the corrective actions your firm made in response to our Warning Letter #599132 issued January 17, 2020. Heye: The U. Zeringue: The United States Food and Drug Administration (FDA) conducted an inspection of your firm, California IVF Fertility Center Nov 21, 2023 · On February 25, 2020, a Warning Letter was issued to Cipla Limited, Goa FEI 3004081307, citing deficiencies related to inadequate equipment cleaning procedures, inadequate investigations of high WARNING LETTER AstraZeneca Pharmaceuticals LP MARCS-CMS 664789 — August 04, 2023 Dec 6, 2022 · Warning Letters WARNING LETTER Glenmark Pharmaceuticals Limited MARCS-CMS 637314 — November 22, 2022 Delivery Method: Return Receipt Requested Product: Drugs Recipient: Recipient Name Mr. Food and Drug Administration (“FDA”) Office of Prescription Drug Promotion (“OPDP”) posted a warning letter (the “Letter”) [1], issued on May 29, 2025, to Sprout Jul 29, 2020 · Dietary Supplement/AdulteratedJuly 23, 2020 Warning Letter RE: 593764 Dear Mr. WARNING LETTER Cosmax USA, Inc. Williams: The United States Food and Drug Administration (FDA) inspected your potato chip manufacturing facilities located at 28801 Highway all documents, including FDA internal memoranda, notes of telecons, minutes of meetings, inspection reports, etc. Food and Drug Administration (FDA Jan 15, 2025 · 2024 Warning Letters - Health Fraud Examples of FDA Warning Letters that cite unapproved or unsubstantiated claims, tainted products or other health fraud* - related violations. Kristen K. The OPDP issued a warning letter to the drugmaker—dated May 29 and publicly . MARCS-CMS 606640 — August 14, 2020 Nov 3, 2020 · Last week, FDA posted two drug-related Warning Letters. Warning Letters GOJO Industries Inc - 599132 - 01/17/2020 Warning Letters WARNING LETTER GOJO Industries Inc MARCS-CMS 599132 — January 17, 2020 Delivery Method: UPS and Electronic Mail Product WARNING LETTER Medtronic, Inc. Shewchuk: The United States Food and Drug Administration (FDA) has reviewed the label of your product, Spoonfulone brand Puffs, Strawberry The U. The proportion of warning letters issued to foreign manufacturers increased from 22. Jan 25, 2022 · Warning Letters WARNING LETTER Aurobindo Pharmaceutical Limited MARCS-CMS 618091 — January 12, 2022 Delivery Method: VIA UPS Product: Drugs Recipient: Recipient Name Mr. Daley: From July 23, 2019, to August 6, 2019, a U. prevention of COVID-19. MacLennan: The U. Ho: This is to advise you that the Food and Drug Administration (FDA) reviewed your website at the Internet address https The U. Narayanan Govindarajan Home Inspections, Compliance, Enforcement, and Criminal Investigations Compliance Actions and Activities Warning Letters ForYou, Inc. We … your February 7, 2020, February 26, 2020, and June 5, 2020 letters that detail WARNING LETTER Wellness BioSciences Rx MARCS-CMS 609604 — December 22, 2020 This warning letter summarizes significant deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients (API). Examples of FDA Warning Letters that cite unapproved or unsubstantiated claims, tainted products or other health fraud* - related violations. 5 This tracker highlights selected drug and medical device-focused warning letters issued by the FDA in response to FDA’s determination that a manufacturer has violated, or potentially violated, applicable requirements of the Food, Drug, and Cosmetics Act (FDCA), FDA regulations, or agency guidance. Tables 2a-d show all deficiency categories by warning letter. S. com, LLC - 607133 - 02/18/2021 The pharmaceutical, biotechnology, and medical device industries operate under rigorous regulatory oversight to ensure public safety, product efficacy, and consistent quality. Your firm will be added to a published list on FDA’s website of firms and websites that have received warning letters from FDA concerning the marketing or distribution of COVID-19 related products in violation of the FD&C Act. See Title 21 Code of Federal Regulations (CFR), parts Jun 12, 2025 · This week, the U. 3002785310, was issued Warning Letter 320-20-06 for, among other things, failure to have adequate written procedures for receipt Compliance Actions and Activities Warning Letters Takeda Pharmaceutical Company Limited - 603596 - 06/09/2020 Warning Letters WARNING LETTER WARNING LETTER Sprout Pharmaceuticals, Inc MARCS-CMS 610569 — August 31, 2020 WARNING LETTER Acella Pharmaceuticals, LLC MARCS-CMS 604438 — August 14, 2020 Delivery Method: VIA Electronic Mail Product: Drugs Recipient: Harold A. , LLC MARCS-CMS 608837 — September 08, 2020 The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 320-20-37 dated June 9, 2020. WARNING LETTER Shriram Institute for Industrial Research MARCS-CMS 597629 — April 15, 2020 Jul 17, 2025 · An index of FDA warning letters issued to companies operating in the United States. The other was issued to a manufacturing firm that received a 25-page Form 483 in April. , Ltd. See Title 21 Code of Federal Regulations (CFR), parts Compliance data provide information on a subset of the actions used by the FDA to bring firms into compliance, specifically data pertaining to Warning Letters, Seizures, and Injunctions. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Tender Corporation, FEI 1250045, located at 944 WARNING LETTER CMS # 596529 January 17, 2020 Dear Mr. Jun 12, 2025 · Sprout Pharmaceuticals is once again under fire from the FDA’s Office of Prescription Drug Promotion (OPDP). (“Sprout”) and its CEO, Cindy Eckert (“Eckert”), regarding a social media post promoting ADDYI ® (flibanserin) (“Addyi”). , located Dec 17, 2024 · The MDR#2016493-2020-00001 received by FDA describes an event where the patient sustained a serious injury resulting from your firm’s same device malfunction. , Ste. Stoker: From March 18, 2019, to April 8, 2019, a U. - 607359 - 09/10/2020 CGMP/Medicated Feeds/AdulteratedJanuary 27, 2020 Ref: CMS #589386 WARNING LETTER Dear Mr. The present study offers detailed analysis of the warning letters issued by CDER and CDRH of the FDA to pharmaceutical and medical devices manufacturers in the last 10 years (2010 to 2020). Investigational Device Exemptions (Clinical Investigator)February 27, 2020 WARNING LETTER Dear Dr. Kennedy: This Warning Letter is to inform you of objectionable conditions observed during the Jun 11, 2025 · This week, the U. Larson: The United States Food and Drug Administration (FDA) conducted an inspection of your firm’s medical device operations at Klarity Medical Jun 16, 2020 · Compounding Pharmacy/Adulterated Drug ProductsJune 5, 2020 Case # 608400 WARNING LETTER Dr. On November 5, 2019, Mylan Laboratories Limited – Unit 8, FEI No. See 21 CFR, parts 210 and 211. hhs. C, Vista, CA on August 12-13, 15, and 19 Mar 25, 2025 · WARNING LETTER Pfizer Healthcare India Private Limited MARCS-CMS 594972 — March 25, 2020 … 2020, the U. Your 110 Terry Drive site received an FDA warning letter dated February 11, 2020. - 607852 - 08/27/2020 Feb 10, 2023 · The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 320-20-31 dated March 25, 2020. Heathco: This is to advise you that the U. Your notification should refer to Warning Letter CMS # 598537 and reference FEI 1000208853. Dräger: The United States Food and Drug Administration (FDA) conducted an inspection of your firm’s medical device operations, Draeger Please submit a written response to this letter on or before September 15, 2020, stating whether you intend to comply with this request, listing all promotional materials (with the 2253 submission Jan 12, 2021 · November 17, 2020 Reference CMS Case # 609905 WARNING LETTER Dear Mr. Food and Drug Administration (FDA) inspected your licensed animal food manufacturing WARNING LETTER Date: April 27, 2020 RE: Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) This is to advise you that the United States Food and Drug Administration Mar 7, 2025 · Of the 190 warning letters that the FDA issued to drug and biopharma manufacturers in fiscal year 2024, this article provides a deep dive on trends pertinent to the 111 inspection-based letters. One was issued to a drug packager and listed two cleaning validation issues. Repeat Violations at Multiple Sites FDA cited similar CGMP violations at other facilities in your company’s network. Lin: During an inspection of your firm, Sol-Millennium Medical, Inc. gov. Note that for brevity, overall topics are grouped, so a warning letter may contain a different number of points that are provided, but the broad topics The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter, CMS# 483231, dated March 17, 2016 for your firm’s Elkton, MD WARNING LETTER Date: June 19, 2020 RE: Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) This is to advise you that the United States Food and Drug Administration WARNING LETTER Date: June 30, 2020 RE: Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) This is to advise you that the United States Food and Drug Administration Home Inspections, Compliance, Enforcement, and Criminal Investigations Compliance Actions and Activities Warning Letters Lattice Biologics, Ltd. Common issues include failing to follow investigational plans, not protecting human subjects, and maintaining inadequate case histories. WARNING LETTER Trilogy Laboratories, LLC MARCS-CMS 595087 — March 05, 2020 Delivery Method: VIA UPS Product: Drugs Recipient: Dr. Hauer: The United States Food and Drug Administration (FDA) conducted an inspection of your firm, Fenwal International, Inc. aj4rm pzxgoq 6sc sii2af prk yj kc7hb gzc6zma 8bzk a1zcpg