1Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination ofdrug products purporting to be sterile are not e stablished, written, and followed.
Inspection Record
Pharmakon Pharmaceuticals, Inc. — FDA 483 Findings
Inspectors Sarah M. Napier · Emily J. OrbanThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Laboratory 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.
3Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding systems for maintaining any equipment used to control the aseptic conditions.
4Equipment and facility
The flow of components, drug product containers, and closures though the building is not designed to prevent contamination.
5Aseptic 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.
6Labeling and packaging
The labels of your firm's drug products do not include infonnation required by section 503B(a)(10) of the Act.
7Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment produce aseptic conditions.
8Equipment and facility
The operations relating to the processing ofpenicillin are not performed in facilities separate from those used for other drug products for human use.
9Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
10Laboratory and QC controls
Drug product container and closure test procedures are deficient in that containers and closures are not tested for conformance in accordance with appropriate written procedures.
11Training and personnel
Clothing ofpersonnel engaged in the processing ofdrug products is not appropriate for the duties they perform.
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.
