Cabrillo Labs Receives No 483s from Recent FDA Audit

On October 5 and 6 the Food and Drug Administration visited our Cabrillo Facility in San Diego, California performing a GLP Laboratory Inspection.

We are happy to report that no FDA-483 was issued.

The general inspection involved GLP studies recently conducted at Cabrillo. Several protocols were reviewed, and one study was chosen for extensive review, including notebook documentation, chromatographic data retrieval from archives and raw data transcription into final reports. The inspection also covered general GLP requirements of computer software validation, organizational charts, job descriptions, instrument files, SOPs, and Master Schedule documentation.