FDA 483 - Boothwyn Pharmacy LLC - June 10, 2025

**FDA 483 Summary for Executives: Boothwyn Pharmacy LLC**

**Company Name:** Boothwyn Pharmacy LLC **Inspection Dates:** May 12, 2025 - June 9, 2025 **Location:** Kennett Square, PA **FEI Number:** 1000076625 **Report Recipient:** John W. Howell Sr., Executive Vice President of Operations

**Inspection Overview:** The FDA conducted an inspection at Boothwyn Pharmacy LLC, a producer of sterile and non-sterile drug products, identifying several critical compliance issues.

**Main Violations/Issues:**

1. **Product Quality and Notification:** The firm released drug products that failed sterility and potency tests without notifying patients. For example, a lot of Tirzepatide/Glycine/Methylcobalamin was dispensed despite failing preliminary testing.

2. **Storage Conditions:** Drug formulations were labeled for storage conditions ("store frozen") not supported by stability studies, contradicting approved product labeling that advises against freezing.

3. **Aseptic Processing:** Multiple breaches in aseptic technique were observed, including improper handling of sterile vials and blocking of "first air" in ISO 5 areas.

4. **Smoke Studies:** Airflow visualization studies were inadequate, failing to demonstrate proper air movement and containment within critical zones.

5. **Facility Conditions:** Production areas had difficult-to-clean surfaces and ceiling tiles with gaps, potentially allowing contamination.

**Regulatory Framework:** The observations are based on the Federal Food, Drug, and Cosmetic Act, particularly concerning the production of sterile drug products.

**Required Actions:** Boothwyn Pharmacy LLC must address the identified issues by implementing corrective actions to ensure compliance with FDA regulations. This includes revising storage conditions, improving aseptic techniques, conducting thorough smoke studies, and upgrading facility conditions to prevent contamination. The company is encouraged to discuss objections or corrective actions with the FDA and submit a detailed response outlining their compliance strategy.