Inspection Record

DNA Pharmacy Services Inc dba Palm Beach Compounding — FDA 483 Findings

US FDAInspected 2015-07-17Published 2024-01-17 3 findingsAseptic processing and sterility assuranceStability and storageEquipment and facility

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

Findings

1Aseptic processing and sterility assurance

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

2Stability and storage

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

3Equipment and facility

Equipment and utensils are not maintained at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.

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.

DNA Pharmacy Services Inc dba Palm Beach Compounding company profile — full history US FDA documents, 2024 Go to Findings search