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

This FDA Form 483 was issued to Mandell's Clinical Pharmacy, located at 7 Cedar Grove Ln, Suite 24, Somerset, NJ 08873-1331, a producer of sterile and non-sterile drug products. The inspection occurred on 06/17/19-06/18/19, 07/01/19-07/02/19, 07/09/19, 07/16/19, and 07/25/19. Ms. Teresa Malanda, RPh, Pharmacist/Owner, was the recipient.

Observations include: 1. The ISO 5 classified area (laminar flow hood for aseptic filling) is located within a non-classified room, which is not HEPA filter equipped. Water was observed dripping from a ceiling vent near the ISO-5 area, raising contamination concerns. 2. Media fills were inadequate. No media fill was performed for the ISO-5 laminar flow hood in the unclassified room. Media fills for the ISO-5 biological safety cabinet in the ISO-7 room used an insufficient number of vials, not representing worst-case batch sizes (ranging from [b] (4) vials). 3. Non-depyrogenated equipment was used in sterile drug production. Specifically, [b] (4