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# Latest FDA Warning Letters
- URL: https://www.fdaweb.com/latest-fda-warning-letters-169/
- Published: 2018-07-17T12:00:00.000Z
- Updated: 2026-09-15T00:19:56.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5141897

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

**Baxter (Claris Injectables Ltd.)** Gujarat, India (7/5): FDA inspected the firm 8/2017 and cited significant GMP violations for finished pharmaceuticals. The firm invalidated out-of-specification results without adequate investigation and scientific justification. FDA also observed an operator recording unreliable data. Additionally, agency investigators observed significant evidence of water damage to the firm’s facility, including warped ceiling panels, puddles of water, and water stains.  
[https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm613538.htm](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm613538.htm?ref=fdaweb.com)

  
**bB BioChem Laboratories** Santa Ana, CA (7/3): FDA inspected the firm 12/2017 and cited significant GMP violations for finished pharmaceuticals.For example, the firm failed to have, for each batch of drug product, appropriate laboratory determinations of satisfactory conformance to final specifications. The firm also failed to conduct at least one test to verify the identity of each component of a drug product. Additionally, the inspection determined that it manufactures unapproved new drug products.  
[https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm613546.htm](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm613546.htm?ref=fdaweb.com)