1Other quality system
Drug products failing to meet established specifications are not rejected.
Inspection Record
Olympia Compounding Pharmacy dba Olympia Pharmacy — FDA 483 Findings
Inspectors Jessica P Mcalister · Susan O Oladeji · Clinton J LottThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Labeling and packaging
The container labels of your outsourcing facility's drug products are deficient.
3Quality unit oversight
The quality control unit lacks responsibility to reject all procedures or specifications impacting on the identity, strength, quality and purity of drug products.
4Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
5Deviation, CAPA, and investigation
There is a failure to thoroughly review any unexplained discrepancy and 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.
6Regulatory reporting and change control
Your outsourcing facility did not submit a report to FDA identifying the drugs compounded during the previous six month period.
7Regulatory reporting and change control
Your outsourcing facility compounds drug products using bulk drug substances that cannot be used in compounding under section 503B because they (a) have been identified in a federal register notice as not being placed on the 503B Bulk List and do not appear on the drug shortage list in effect under section 506E of the Act or (b) appear on the 503B Category 2 (bulk drug substances identified by FDA as presenting significant safety risk).
8Stability and storage
Results of stability testing are not used in determining expiration dates.
9Process validation
Time limits are not established when appropriate for the completion of each production phase to assure the quality of the drug product.
10Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.
11Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency paiiiculate air filters under positive pressure.
12Quality unit oversight
Approved components, drug product containers and closures are not retested or reexamined as appropriate for identity, strength, quality and purity after exposure to conditions that might have an adverse effect with subsequent approval or rejection by the quality control unit.
13Labeling and packaging
The labels of your outsourcing facility's drug products are deficient.
About this record
Extracted automatically from the document US FDA published on 2022-09-26. 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.
