1Quality unit oversight
The quality control unit lacks responsibility to approve and reject all procedures or specifications impacting on the identity, strength, quality, and purity ofdrug products.
Inspection Record
Teva Parenteral Medicines, Inc. — FDA 483 Findings
Inspectors Binh T Nguyen · Joey V. Quitania · Thomas J. Arista and 1 moreThe 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
Procedures designed to prevent microbiological contamination ofdrug products purporting to be sterile are not established and written.
3Other quality system
Testing and relea.se ~f drug product for distribution do not include appropriate laboratOly determination of satisfactory I confunnance to thennat specIfications pnorto release.
4Quality unit oversight
l in-process materials are not tested for quality and purity and approved or rejected by the quality control unit during the production process.
5Equipment and facility
Equipment used in the manufacture, processing, packing or holding ofdrug products is not ofappropriate design to facilitate operations for its intended use.
6Quality unit oversight
Acceptance criteria for the sampling and testing conducted by the quality control unit is not adequate to assure that batches of drug products meet appropriate statistical quality control criterla as a condition for their approval and release.
7Quality unit oversight
The responsibilities and procedures applicable to the quality control unit are not in writing.
8Equipment and facility
II II Equipment and utensils are not cleaned and sanitized at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity ofthe drug product: - I ;~;;;,;,:~:;,o:;::~~oo:;::~~;~,:::;;:;;::;:~.::"~::,:::,~;,~,=,",,,oo "',~ (b) (4) "-~ ., ,- C.
9Laboratory and QC controls
Each batch ofdrug product required to be free ofobjectionable microorganisms is not tested through appropriate laboratory testing.
10Deviation, CAPA, and investigation
There is a failure to thorougWy review any unexplained discrepancy whether or not the batch has been already distributed.
11Material and supplier control
Each lot ofa component liable to objectionable microbiological contamination is deficiently subjected to microbiological tests before use.
12Deviation, CAPA, and investigation
Investigations ofan unexplained discrepancy did not extend to other batches ofthe same drug product and other drug products that may have been associated with the specific failure or discrepancy.
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.
