FDA EIR - Pyramid Laboratories, Inc. - September 29, 2021

An FDA inspection of Pyramid Laboratories, Inc., located in Costa Mesa, CA, was conducted from September 20-29, 2021. This inspection served as both a Good Manufacturing Practice (GMP) review and a post-approval inspection for NDA 212097, covering the company's Glucagon injectable products. The inspection focused on key systems including Quality, Production, Facilities and Equipment, Materials, and Laboratory. At the conclusion, the FDA issued a five-item Form 483, detailing observations of objectionable conditions. Key issues included a fill-weight check sampling plan implemented without adequate scientific rationale, and a differential pressure monitoring system in aseptic processing areas with delayed alert times unsupported by scientific justification. Additionally, the quality unit did not consent to the use of integration during chromatography evaluation. Further observations highlighted that laboratory equipment was not appropriately qualified or calibrated for its intended use, and the firm lacked proper controls over computer systems utilized for HPLC analysis. Pyramid Laboratories committed to providing a written response to these observations.