FDA EIR - Pyramid Laboratories, Inc. - February 03, 2021

A recent FDA pre-license inspection of Pyramid Laboratories, Inc., a contract sterile drug manufacturer located in Costa Mesa, CA, was conducted from January 27 to February 3, 2021. This inspection aimed to evaluate the facility's readiness for commercial manufacturing in accordance with applicable sections of CPGM 7356.002M, CPGM 7346.832, and ICH Q7, under the Food, Drug, and Cosmetic Act. The inspection covered Quality, Facilities/Equipment, Production, Materials, and Laboratory Control Systems.The inspection resulted in one FDA Form 483 observation, indicating that procedures designed to prevent microbiological contamination of sterile drug products were not adequately written or followed. Specific issues included operators failing to sanitize gloves after touching non-sterile items before aseptic operations within the Grade A Restricted Access Barrier System (RABS) fill line, and not sanitizing the RABS Grade A inner surface after entry from a Grade B area. Furthermore, non-sterile equipment was inappropriately placed at knee height within the RABS fill line, violating "working level" protocols. A verbal recommendation also highlighted a procedure that allowed Grade C air to vent into the Grade A RABS during filter setup, posing a potential contamination risk. In response, Pyramid Laboratories, Inc. management committed to addressing these observations and submitting a formal reply within 15 business days. The firm was also advised to assess the potential impact of the identified air venting procedure. No issues from a previous 2019 inspection regarding drug product release testing were noted as adequate.