FDA 483 - hiers enterprises, llc - November 10, 2021

The FDA Form 483 details observations from an inspection concerning the production of drug products, including hazardous drugs and beta-lactam drugs.

**Violations and Observations:**

1. **Inadequate Containment and Cleaning for Hazardous Drugs:** * **Utensil Cleaning:** A Pharmacy Technician used a visibly soiled cloth towel for cleaning and did not use deactivating/oxidizing agents for instruments or work surfaces after compounding hormone-containing products (Estradiol/Progesterone/Testosterone troches, Metronidazole in HRT cream, Baclofen/Diclofenac/Gabapentin/Lidocaine/Prilocaine cream). * **Containment:** Compounding of multiple hazardous drug lots (e.g., Estradiol/Progesterone/Testosterone troches, Amitriptyline/Ketamine/Lidocaine cream, Estradiol/Testosterone suppositories) occurred in a general lab area lacking air quality or flow control measures, with raw materials observed in the open lab. * **Utensil Soaking:** Compounding utensils were placed in a solution that did not fully cover product contact surfaces, leaving parts of items like plastic jars, measuring cylinders, glass mortars, and beakers unsanitized, and not exposed for the required duration.

2. **Inadequate Containment, Segregation, and Cleaning for Beta-Lactam Drugs:** * The firm compounded beta-lact