1Process validation
Written production and process control procedures are not followed in the execution of production and process control functions and documented at the time of performance.
Inspection Record
OPS International Inc dba Olympia Pharmaceuticals — FDA 483 Findings
Inspectors Mindy M Chou · Michelle LinThe inspectors who signed the published document.Inspector lookup
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.
3Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
4Aseptic processing and sterility assurance
Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to aseptic processing of drug products.
5Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and followed.
6Process validation
Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess.
7Laboratory and QC controls
The written stability program for drug products does not include reliable, meaningful and specific test methods.
8Material and supplier control
Each component is not added to the batch by one person and verified by a second person ..
About this record
Extracted automatically from the document US FDA published on 2026-10-01. 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.
