> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Latest FDA Warning Letters
- URL: https://www.fdaweb.com/latest-fda-warning-letters-162/
- Published: 2018-05-22T12:00:00.000Z
- Updated: 2026-09-15T00:06:52.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141502

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

**Emmett F. Branigan** Bellingham, WA (5/7): FDA inspected the physician’s office 1/29-31 and documented significant GMP deviations involving human cells, tissues, and cellular and tissue-based products (HCT/Ps) regulations. For example, his clinic was cited for failing to test a donor specimen for evidence of infection due to relevant communicable disease agents. It also was cited for failing to establish and maintain procedures for all steps performed in testing, screening, and determining donor eligibility, and complying with all other requirements of Subpart C “Donor Eligibility.”  
[https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm607671.htm](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm607671.htm?ref=fdaweb.com)

**Cerno Pharmaceuticals** Miami, FL (5/15): FDA inspected the firm’s drug manufacturing facility 11/2017 and cited significant GMP violations for finished pharmaceuticals. For example, the firm failed to withhold from use each lot of components, drug product containers, and closures until the lot had been sampled, tested, or examined, as appropriate, and released for use by the quality control unit. It also failed to follow adequate written procedures for cleaning and equipment maintenance.  
[https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm607695.htm](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm607695.htm?ref=fdaweb.com)

**Nox Bellcow Cosmetics** Zhongshan City, China (5/9): FDA inspected the firm’s drug manufacturing facility 9/2017 and cited significant GMP violations for finished pharmaceuticals. For example, the firm failed to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products. The firm also failed to conduct at least one test to verify the identity of each component of a drug product. Additionally, it failed to validate and establish the reliability of its component supplier’s test analysis at appropriate intervals.  
[https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm607820.htm](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm607820.htm?ref=fdaweb.com)