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# Latest FDA Warning Letters
- URL: https://www.fdaweb.com/latest-fda-warning-letters-187/
- Published: 2019-03-05T12:00:00.000Z
- Updated: 2026-09-15T01:09:51.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5143532

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

**Actavis Laboratories** Davie, FL (2/1): FDA inspected the firm 7/2018 and cited significant GMP violations for finished pharmaceuticals. For example, the firm failed to establish adequate written procedures for production and process control designed to assure that drug products manufactured have the identity, strength, quality, and purity they purport. Actavis also failed to establish control procedures to monitor the output and to validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product. Additionally, the company 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.  
[https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm632120.htm](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm632120.htm?ref=fdaweb.com)

**AndaPharm** Fort Lauderdale, FL (2/28): FDA inspected the firm 7/2018 and cited significant GMP violations for finished pharmaceuticals. For example, AndaPharm failed to establish and follow adequate written procedures for cleaning and maintenance of equipment. The company also failed to establish and follow an adequate written testing program designed to assess the stability characteristics of its drug products.  
[https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm632415.htm](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm632415.htm?ref=fdaweb.com)

**New Era Naturals** Durango, CO (1/30): FDA inspected the firm 4/2018 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. New Era also failed to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality. Additionally, the company failed to establish and follow written procedures for the preparation of master production and control records designed to assure uniformity from batch to batch.  
[https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm632080.htm](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm632080.htm?ref=fdaweb.com)

**Vilvet Pharmaceuticals** Chester Springs, PA (2/25): FDA inspected the firm 6/2018 and cited significant GMP violations for finished pharmaceuticals. For example, the firm failed to establish an adequate quality control unit and procedures applicable to the 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. Vilvet also failed to establish adequate written responsibilities and procedures for reviewing batches made by its supplier. Additionally, the Warning Letter recommends that the company retain a third-party regulatory consultant to help with GMP compliance.  
[https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm632119.htm](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm632119.htm?ref=fdaweb.com)