Inspection Record

STAQ Pharma, Inc. — FDA 483 Findings

US FDAInspected 2020-09-03Published 2020-11-02 5 findingsAseptic processing and sterility assuranceDeviation, CAPA, and investigationLabeling and packaging

Inspectors Michael A CharlesThe inspectors who signed the published document.Inspector lookup

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

Findings

1Aseptic processing and sterility assurance

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

2Deviation, CAPA, and investigation

Written records of investigations into unexplained discrepancies do not always include the conclusions and follow-up.

3Aseptic 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.

4Labeling and packaging

The labels of your outsourcing facility's drug products are deficient.

5Aseptic processing and sterility assurance

Aseptic processing areas are deficient regarding the system for cleaning an ddisinfecting the room and equipment to produce aseptic conditions.

About this record

Extracted automatically from the document US FDA published on 2020-11-02. 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.

STAQ Pharma, Inc. company profile — full history US FDA documents, 2020 Go to Findings search