The FDA handed Mexican drugmaker Degasa a Form 483 with 12 observations listing the many noncompliance issues found during an inspection of its Jiutepec, Morelos facility, including faulty recordkeeping, inadequate testing and poor quality controls.
In a September inspection, the investigator found the facility did not thoroughly review unexplained discrepancies. An out-of-specification investigation of a batch did not record raw data for the initial OOS result and did not document why the sample was re-tested.
The firm’s system for releasing and quarantining product lacked specifications for changing a product from quarantine to release status. The facility also lacked the capability to ensure integrity of data through audit trails.