1Complaint and recall handling
Procedures describing the handling of all written and oral complaints regarding a d rug product are not followed.
Inspection Record
Olympia Compounding Pharmacy dba Olympia Pharmacy — FDA 483 Findings
Inspectors Kayla V Sprague · Jessica P Mcalister · Libia M Lugo and 1 moreThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Other quality system
Dr u g products failing to meet established specifications are not rejected.
3Regulatory reporting and change control
Your outsourcing facility has not submitted a report to FDA identifying a product compounded during the previous six months as required by section 503B(b )(2)(A) of the Federal Food, Dr ug, and Cosmetic Act (FD&C Act).
4Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring enviro nmental conditions .
5Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic process.
6Process validation
Your firm failed to establish 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.
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.
About this record
Extracted automatically from the document US FDA published on 2024-08-06. 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.
