1Contamination control
Protective apparel is not worn as necessary to protect drng products from contamination.
Inspection Record
OPS International Incorporated D/B/A Olympia Pharmacy — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Labeling and packaging
Product Labeling: The labels of some of your outsourcing facility's drug products do not include information required by section 503B(a)(10)(A).
3Quality unit oversight
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
4Regulatory reporting and change control
Product Reporting: Your outsourcing facility has not subinitted a report to FDA identifying a product compounded during the previous six months as required by section 503B(b )(2)(A).
5Labeling and packaging
The containers of your outsourcing facility's drug products do not include information required by section 503B(a)(10)(B).
6Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written and followed.
7Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.
8Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
9Laboratory and QC controls
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications prior to release.
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.
