Inspection Record

Jajco Inc. dba Anchor Drugs Pharmacy — FDA 483 Findings

US FDAInspected 2016-06-22Published 2024-01-17 6 findingsDeviation, CAPA, and investigationStability and storageAseptic processing and sterility assuranceEquipment and facility

Inspectors Stephanie A Slater · Anh Lac · Henry K LauThe inspectors who signed the published document.Inspector lookup

View the regulator's official source The source document is always the basis for judgement.

Findings

1Deviation, 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.

2Stability and storage

There is no written testing program designed to assess the stability characteristics of drug products.

3Aseptic processing and sterility assurance

Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.

4Equipment and facility

Routine calibration, inspection and checking of equipment is not performed according to a written program designed to assure proper performance.

5Aseptic processing and sterility assurance

Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written and followed.

6Aseptic processing and sterility assurance

Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air filters under positive pressure.

About this record

Extracted automatically from the document US FDA published on 2024-01-17. 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.

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