1Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding systems for maintaining any equipment used to contJ.·ol the aseptic conditions.
Inspection Record
Apothecary Pharma LLC — FDA 483 Findings
Inspectors Justine Tomasso · Sarah M Gauna · Xiaohui ShenThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Quality unit oversight
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
3Contamination control
Protective apparel is not worn as necessary to protect drug products from contamination.
4Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.
5Regulatory 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, Drug, and Cosmetic Act (FD&C Act).
6Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written and followed.
7Documentation and records
Batch production and control records do not include in-process and laboratory control results for each batch of drug product produced.
8Aseptic 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 and sterilization process.
About this record
Extracted automatically from the document US FDA published on 2025-06-02. 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.
