FDA EIR - Pyramid Laboratories, Inc. - April 11, 2019

The FDA conducted a pre-approval inspection of Pyramid Laboratories, Inc., a contract sterile drug manufacturer located in Costa Mesa, CA, from April 1 to April 11, 2019. This inspection focused on the firm's readiness for commercial manufacturing of pre-filled syringes for NDA 212097, G-PEN (Glucagon Injection 5 mg/ml), under regulatory guidelines for drug manufacturing and pre-approval inspections. During the inspection, one FDA Form 483 observation was issued, citing the company's failure to establish appropriate release testing specifications for impurity levels. Additionally, verbal discussions highlighted concerns regarding the clarity of re-establishing system suitability in testing sequences, observed data integrity issues, and security concerns related to release testing. The report also detailed issues within the firm's quality system, including instances where investigations into non-conformances and out-of-specification results lacked thorough internal root cause analysis, relying instead on client-provided conclusions. Furthermore, the inspection identified weaknesses in environmental monitoring procedures, specifically regarding the definition of "adverse trends" and the investigation of alert-level excursions. Practices observed in incoming component examination documentation raised data integrity questions, as former quality assurance staff pre-filled results. The firm also lacked a documented policy for conducting on-site supplier audits. Pyramid Laboratories was required to provide written responses to the FDA Form 483 observation and initiated some corrective actions during the inspection.