1Aseptic 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.
Inspection Record
Hieber’s Pharmacy — FDA 483 Findings
Inspectors Gayle S Lawson · Lisa B OrrThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Stability and storage
There is no writ en testing program designed to assess the stability characteristics of drug products.
3Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contaminatiob of drug products purporting to be sterile ar e not established.
4Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include validation of the sterilization process.
5Aseptic processing and sterility assurance
Drug product were not sterilized and processed to remove pyrogenic properties to assure that they are suitabl e for their intended use.
6Training and personnel
Clothing of personnel engaged in the drug products is not app ropriate for the duties they perform.
7Laboratory 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 of each active ingredient prior to release.
8Aseptic processing and sterility assurance
Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to aseptic processing of drug products.
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.
