FDA 483 - Mandell's Clinical Pharmacy - July 25, 2019

This FDA Form 483 document details observations from an inspection of Mandell's Clinical Pharmacy, a producer of sterile and non-sterile drug products, located at 7 Cedar Grove Ln, Suite 24, Somerset, NJ 08873-1331. The inspection was conducted on multiple dates between June 17, 2019, and July 25, 2019. The report was issued to Ms. Teresa Malanda, RPh, Pharmacist/Owner.

Key observations include: 1. **Facility Design and Control:** An ISO 5 classified laminar flow hood for aseptic filling of sterile fertility drug products is located within a non-classified room, which is not HEPA filter equipped. Water was observed dripping from a ceiling vent near this ISO 5 area, raising contamination concerns. 2. **Aseptic Process Validation:** Media fills were not performed to adequately simulate aseptic production operations. Specifically, no media fill was performed for the ISO 5 laminar flow hood in the unclassified room. Additionally, media fills for the ISO 5 biological safety cabinet used an insufficient number of units (b)(4) compared to typical batch sizes ranging from (b)(4) vials, failing to represent worst-case conditions. 3. **Equipment Sterilization:** Non-depyrogenated equipment was used in sterile drug production. The (b)(4) used for mixing drug components