1Regulatory reporting and change control
Your outsourcing facility did not submit a report to FDA identifying the drugs compounded during the previous six month period.
Inspection Record
Pine Pharmaceuticals LLC — FDA 483 Findings
Inspectors Tekalign WondimuThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Quality unit oversight
The quality control unit lacks the responsibility and authority to approve and reject all in process materials and drug products.
3Aseptic processing and sterility assurance
Personnel were observed conducting aseptic manipulations where the movement of "first air" in the ISO 5 area is blocked or disrupted.
4Material and supplier control
There is a failure to thoroughly review 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.
5Equipment and facility
Production areas have difficult to clean or contain porous, particle generating, or visibly dirty equipment or surfaces.
6Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not followed.
7Aseptic processing and sterility assurance
Smoke studies were inadequately performed under dynamic conditions.
About this record
Extracted automatically from the document US FDA published on 2023-11-01. 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.
