Inspection Record

Precision Pharmacy Center LLC — FDA 483 Findings

US FDAInspected 2016-06-17Published 2024-01-17 3 findingsStability and storageAseptic processing and sterility assurance

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

Findings

1Stability and storage

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

2Aseptic processing and sterility assurance

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

3Aseptic processing and sterility assurance

Each batch of drug product purporting to be pyrogen-free is not laboratory tested to determine conformance to such requirements.

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.

Other records for this company

2015-07-17 · US FDA · 5 findings
Precision Pharmacy Center LLC findings history — including this company's other documents US FDA documents, 2024 Go to Findings search