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# Latest FDA Warning Letters
- URL: https://www.fdaweb.com/latest-fda-warning-letters-142/
- Published: 2017-12-05T12:00:00.000Z
- Updated: 2026-09-14T23:04:59.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5140274

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

**Hangzhou Facecare Cosmetics Co.** Hangzhou, Zhejiang, China (11/17): FDA inspected the firm in June and cited significant GMP violations for finished pharmaceuticals. For example, the firm failed to have, for each batch of drug product, an appropriate laboratory determination of satisfactory conformance to final specifications for the drug product. It also failed to test samples of each component for conformity with all appropriate written specifications for identity, purity, strength, and quality.  
[https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm586711.htm](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm586711.htm?ref=fdaweb.com)

**Hand Biomechanics Lab**, Sacramento, CA (11/16): FDA inspected the firm in June and cited medical device reporting violations associated with its bone fixation fastener systems. For example, the firm failed to submit a report to FDA no later than 30 calendar days after the day that the firm received or otherwise became aware of information that reasonably suggested that a device that the firm markets may have caused or contributed to a death or serious injury. The firm was also found to not have adequately developed, maintained and implemented written MDR procedures.  
[https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm587328.htm](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm587328.htm?ref=fdaweb.com)

**PharmScript** Somerset, NJ (8/23): FDA inspected the firm’s drug compounding operations 10/2016 and cited serious deficiencies in its practices for producing sterile drug products. For example, the firm’s facility design is deficient for sterile drug production because aseptic processing occurred in an unclassified room. Additionally, the firm did not use a sporicidal agent or sterile wipes as part of its disinfection program for aseptic processing areas.  
[https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm587027.htm](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm587027.htm?ref=fdaweb.com)