1Laboratory and QC controls
Testing and release of drug product for distribution do not include appropriate laboratory determination ofsatisfactory conformance to the final specifications prior to release.
Inspection Record
Ionia Pharmacy — FDA 483 Findings
Inspectors Roger F. ZabinskiThe 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
Each batch ofdrug product purporting to be pyrogen-free is not laboratory tested to determine conformance to s uch requirements.
3Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
4Contamination control
Protective apparel is not worn as necessary to protect drug products from contamination.
5Documentation and records
Batch product ion and control records do not include complete information relating to the production and control of each batch.
6Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and followed.
7Contamination control
Container closure systems do not provide adequate protection against foreseeable external factors in storage and use that can cause deterioration or contamination ofthe drug product.
8Stability and storage
Results ofstability testing are not used in determining appropriate storage conditions.
9Material and supplier control
Each lot ofa component that is liable to microbiological contamination that is objectionable in view of its intended use is not subjected to microbiological tests before use.
10Equipment and facility
Equipment and utensils are not cleaned at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
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.
