Mexican Drugmaker Cited for Multiple Violations
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.
The company did not perform sampling according to standard operating procedures, leading to an inadequate number of containers being sampled for release testing, and the facility’s stability program for drug products did not assess product degradation and its effect on product quality over time. Final testing was also not performed on products for proper pH and active ingredient content.
The firm also failed to include all records in its electronic system, and there were discrepancies in the electronic inventory. The investigator noted that approximately 166 boxes listed in the inventory were not present in the warehouse.
The Form 483 noted the firm’s quality control unit did not review laboratory, environmental monitoring and cleaning record documents, for errors. Laboratory records did not include all data recorded during testing, and holding time limitations for in process products were not established to assure their quality.
In addition, reserve samples stored in the facility were not visually evaluated annually for deterioration; distribution records were missing required information about the product; validation of manufacturing processes were not performed; and the personnel in charge of overseeing the microbiology and chemistry laboratories also performed analyses.