FDA EIR - Pacific BioLabs - March 19, 2018

An FDA inspection of Pacific BioLabs, a contract testing facility in Hercules, CA, was conducted from March 8-19, 2018. The cGMP inspection, focusing on analytical and microbiological operations, identified four significant deficiencies, resulting in the issuance of a Form FDA 483. The main issues included a failure to implement adequate software controls for computer systems generating analytical data, where analysts held administrator roles that allowed for data manipulation. The firm also failed to consistently investigate unexplained discrepancies and implement effective corrective and preventive actions, evident in cases of improper sample storage and delayed sample processing without thorough root cause analysis. Furthermore, the inspection noted the use of incubators that did not consistently maintain specified temperature ranges, with temperature excursions occurring without proper investigation into their impact on stored samples. Finally, the Quality Assurance unit demonstrated a backlog in timely review and approval of critical documents, such as Out-of-Specification event logs and equipment calibration certificates. These observations highlight non-compliance with Good Manufacturing Practices (cGMP) regulations, particularly concerning laboratory controls and quality unit responsibilities. Pacific BioLabs management acknowledged the observations and committed to providing a formal response to the FDA 483 within 15 business days, outlining their corrective actions.