1Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not written and followed.
Inspection Record
PQ Pharmacy LLC — FDA 483 Findings
Inspectors Michael Z Weigman · Saundrea A MunroeThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Quality unit oversight
The responsibilities and procedures applicable to the quality control unit are not in writing.
3Computer system validation
Records of the inspections of automatic, mechanical or electronic equipment, including computers or related systems are not maintained.
4Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic process.
5Equipment and facility
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use.
6Laboratory and QC controls
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures designed to assure that drug product containers conform to appropriate standards of identity, strength, quality and purity.
7Deviation, CAPA, and investigation
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
About this record
Extracted automatically from the document US FDA published on 2026-09-22. The source is available at the link above.
This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.
Translation and classification are automated and may differ in nuance from the source.
