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# Latest FDA Warning Letters
- URL: https://www.fdaweb.com/latest-fda-warning-letters-184/
- Published: 2019-02-05T12:00:00.000Z
- Updated: 2026-09-15T01:00:12.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5143305

FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter.

**Hangzhou Zhongbo Industrial Co.**, Zhejiang, China (11/27/2018): FDA inspected the firm 4/2018 and cited significant GMP violations for finished pharmaceuticals. The company failed to have, for each batch of drug product, an appropriate laboratory determination of satisfactory conformance to final specifications. It also failed to establish and follow an adequate written testing program designed to assess the stability characteristics of its drug products and to use results of such stability testing to determine appropriate storage conditions and expiration dates. FDA said the firm’s quality unit is not able to fully exercise its authority and responsibilities, and it recommended that a consultant be retained to assist it in achieving GMP compliance.  
[https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm630081.htm](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm630081.htm?ref=fdaweb.com)

**Longbow First Aid Products Manufactory** Foshan, China (12/14/2019) FDA inspected the firm 4/2018 and cited significant GMP violations for finished pharmaceuticals. For example, Longbow does not have, for each batch of drug product purporting to be sterile, an appropriate laboratory determination of satisfactory conformance to final specifications. The company also failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products.  
[https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm630718.htm](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm630718.htm?ref=fdaweb.com)

**Lymol Medical** Woburn, MA (1/8): FDA has determined that the firm failed to comply with a milestone date for completing a postmarketing requirement (PMR) for its NDA for sterile talc powder. Failure to comply with PMR milestone dates without demonstrating good cause renders the product misbranded. FDA says the violation is concerning from a public health perspective because the agency is aware of lead content in sterile talc, and failure to conduct the PMR impedes the evaluation of neurological, reproductive, developmental, immune, cardiovascular, and renal toxicities from lead exposure through use of the product.  
[https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm630182.htm](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm630182.htm?ref=fdaweb.com)