1Contamination control
Protective apparel is not worn as necessary to protect drug products from contamination.
Inspection Record
Innovative Compounding Pharmacy — FDA 483 Findings
Inspectors Daniel J. Roberts · Linda F. MurphyThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Equipment and facility
Buildings used in the manufacture, processing, packing or holding ofdrug products are not maintained in a clean and sanitary condition.
3Laboratory and QC controls
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the identity and strength ofeach active ingredient prior to release.
4Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination ofdrug products purporting to be sterile are not followed.
5Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room to produce aseptic condit ions.
6Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding systems for maintaining any equipment used to control the aseptic conditions.
7Stability and storage
Results ofstability testing are not used in determining appropriate storage conditions and ex piration dates.
8Contamination control
The control systems necessary to prevent contamination or mix-ups are deficient.
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.
