- Reference #:
Recipient NameMs. Rosemary E. Mihalko, RPh
- Hieber's Pharmacy
3500 5th Avenue
Pittsburgh, PA 15213-3337
- Issuing Office:
- Division of Pharmaceutical Quality Operations I
- (973) 331-4900
Dear Ms. Mihalko:
The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our warning letter #15-PHI-20, dated September 20, 2015, and our warning letter #542220, dated December 5, 2017. Based on our evaluation, it appears that you have adequately addressed the violations contained in these warning letters.
You are expected to take all necessary steps to ensure compliance with the Federal Food, Drug, and Cosmetic Act and FDA’s implementing regulations. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
Program Division Director
Office of Pharmaceutical Quality Operations
Division I/New Jersey District