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# Latest FDA Warning Letters
- URL: https://www.fdaweb.com/latest-fda-warning-letters-147/
- Published: 2018-01-23T12:00:00.000Z
- Updated: 2026-09-14T23:16:11.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140578

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

**BBCOS** Cherasco, Italy (11/29/2017): FDA inspected the firm 6/2017 and cited significant GMP violations for finished pharmaceuticals. For example, the firm failed to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product. It also failed to ensure the identity of components sourced from various suppliers, including your active ingredients.  
[https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm592712.htm](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm592712.htm?ref=fdaweb.com)

**Beauty Manufacturing Solutions** Coppell, TX (1/12): FDA inspected the firm 6/2017 and citedsignificant GMP violations for finished pharmaceuticals. For example, the firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications. In addition, the firm failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity.[https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm592684.htm](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm592684.htm?ref=fdaweb.com)

**BioModeling Solutions** Beaverton, OR (1/12): FDA inspected the firm 9/2017 an cited GMP deviations associated with the manufacturing of dental medical devices. For example, the firm failed to establish procedures for design controls. The firm also failed to establish and maintain procedures for corrective and preventive actions.  
[https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm592704.htm](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm592704.htm?ref=fdaweb.com)

**Wong Lap Kwong Medicine Co.** Hong Kong, China (1/11): FDA inspected the firm 9/2017 and cited significant GMP violations for finished pharmaceuticals. The firm failed to establish adequate written responsibilities and procedures applicable to the quality control unit. The firm also failed to ensure the identity of components, including your active ingredients and excipients from various suppliers.  
[https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm592846.htm](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm592846.htm?ref=fdaweb.com)