Latest FDA Warning Letters

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

Skylark CMC Pvt. Ltd. Gujarat, India (12/3): FDA attempted to inspect the drug manufacturing facility in June but employees refused access to the manufacturing area. The firm also refused to provide FDA-requested records. The agency placed the firm on Import Alert 99-32 on 11/8.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm627878.htm

Zhejiang Huahai Pharmaceutical Co. Taizhou Zhejiang, China (11/29): FDA inspected the firm’s drug manufacturing facility in August and cited GMP deviations for active pharmaceutical ingredients (valsartan). For example, the firm’s quality unit failed to ensure that quality-related complaints are investigated and resolved. The firm also failed to evaluate the potential effect that changes in the manufacturing process may have on the quality of its API. FDA recommended that the firm retain a GMP consultant to evaluate operations and assist it in meeting GMP requirements.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm628009.htm