1Laboratory 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.
Inspection Record
US Compounding Inc. — FDA 483 Findings
Inspectors Kimberley A. Hoefen · Signatur Erika V. ButlerThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the equipment to produce aseptic conditions.
3Aseptic processing and sterility assurance
Each batch of drug product purporting to be sterile and pyrogen-free is not laboratory tested to determine conformance to such requirements.
4Labeling and packaging
The labels for the drug products and drug product containers you produce do not contain information required by section 503B(a)(10) Specifically, I.
5Equipment and facility
Buildings used in the mannfucture, processing, packing or holding of drug products are not maintained in a clean and sanitary condition.
6Equipment and facility
ADDRESS 1270 Don' s Lane ESTA8USHMEHT IHSPl<C eo outsourcin facility Container closure systems do not provide adequate protection against foreseeable external factors in storage and use that can cause deterioration or contamination of the drug product.
7Aseptic processing and sterility assurance
Procedures designed to prevent microbiological coniamination of drug products purporting to be sterile are not established.
8Contamination control
Protective apparel is not worn as necessary to protect drug products from contamination.
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.
