1Deviation, CAPA, and investigation
Written records are not made of investigations into unexplained discrepancies.
Inspection Record
Precision Equine LLC — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Material and supplier control
Component testing is deficient in that each component is not tested for conformity with all appropriate written specifications for purity, strength, and quality.
3Equipment and facility
Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent malfunctions and contamination that would alter the safety, identity, strength, quality or purity of the drug product.
4Laboratory and QC controls
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications and identity and strength of each active ingredient prior to release.
5Quality unit oversight
The quality control unit lacks the responsibility and authority to approve and reject all components.
6Laboratory and QC controls
Each batch of drug product required to be free ofobjectionable microorganisms is not tested through appropriate laboratory testing.
7Stability and storage
There is no written testing program designed to assess the stability characteristics of drug products.
About this record
Extracted automatically from the document US FDA published on 2024-01-25. 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.
