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.

Auro Pharmacies, La Habra, CA (6/3): FDA inspected the firm 7/2018 and cited serious deficiencies in its practices for producing sterile drug products. For example, FDA investigators observed vermin in the company’s production areas. Additionally, its ISO 5 classified aseptic processing areas had visibly dirty equipment and surfaces. To view the letter, click here.

Homeocare Laboratories, Yonkers, NY (6/22): FDA inspected the firm 12/2019 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 for its drug products. Homeocare also 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.