Inspection Record

Pharmacy Creations — FDA 483 Findings

US FDAInspected 2016-09-01Published 2024-01-17 3 findingsAseptic processing and sterility assuranceStability and storage

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.

2Aseptic processing and sterility assurance

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

3Stability and storage

An adequate number of batches of each drug product are not tested to determine an appropriate expiration date.

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

2016-09-01 · US FDA · 5 findings
Pharmacy Creations findings history — including this company's other documents US FDA documents, 2024 Go to Findings search