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# Latest FDA Warning Letters
- URL: https://www.fdaweb.com/latest-fda-warning-letters-9/
- Published: 2020-01-28T12:00:00.000Z
- Updated: 2026-09-14T16:00:10.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5145949

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

**Baja Fur** City of Industry, CA (12/13): FDA inspected the firm in July and cited significant GMP violations for finished pharmaceuticals. For example, the company failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications. The firm also failed to prepare batch production and control records that include documentation of the accomplishment of each significant step in the manufacture, processing, packing, or holding of each batch. To view the letter, click [here](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/baja-fur-sa-de-cv-590791-12132019?ref=fdaweb.com).

**Dental-Kosmetik, Dresden**, Germany (1/16): FDA inspected the company in July 15 and cited significant GMP violations for finished pharmaceuticals. For example, the firm failed to establish written procedures for production and process controls. It also failed to establish and follow an adequate written testing program designed to assess the stability characteristics of its drug products. To view the letter, click [here](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/dental-kosmetik-gmbh-co-kg-591351-01162020?ref=fdaweb.com).

**Draegar Medical Systems, Luebeck,** Germany (1/17): FDA inspected the company in September and determined that modifications to its patient monitoring systems require a new 510(k). FDA also found the devices adulterated because they were not manufactured under Quality System regulation requirements. For example, the company failed to establish and maintain procedures for validating the device design that includes a risk analysis, where appropriate. Additionally, the firm failed to establish and maintain procedures for verifying that the device design meets design input requirements. To view the letter, click [here](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/draegar-medical-systems-inc-596529-01172020?ref=fdaweb.com).

**Sunstar Guangzhou,** Guangdong Sheng, China (1/22): FDA inspected the firm 6/2019 and cited significant GMP violations for finished pharmaceuticals. For example, the company failed to perform, for each batch of drug product, an appropriate laboratory determination of satisfactory conformance to final specifications. Additionally, it failed to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality. To view the letter, click [here](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sunstar-guangzhou-ltd-592906-01222020?ref=fdaweb.com).