The FDA hit Nexgen Pharma with a Form 483 after an inspection of its Irvine, California facility revealed procedural and documentation issues.
The agency investigator observed that the firm used unqualified equipment in its manufacturing processes. For example, an uncalibrated filling machine was not qualified for use and there were no written directions for preventative maintenance or operating procedures.
The agency also flagged problems with data quality. User privileges for various groups were not defined in facility software programs used in the quality control and research and development labs, and the firm’s batch records were inadequate.
Results from packaging and labeling facility inspections were not documented in batch production records, and written records were not always kept of investigations into batch failures.
In addition, the firm’s lab procedures did not have scientifically sound and appropriate test procedures to confirm the products met quality, purity, strength and identity standards.
The company also did not properly receive raw materials in accordance with warehouse standard operating procedures, failing to document a damaged case of raw materials.