1Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
Inspection Record
BAYCARE INTEGRATED SERVICE CENTER — FDA 483 Findings
Inspectors Joanne E KingThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Deviation, CAPA, and investigation
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
3Quality unit oversight
The responsibilities and procedures applicable to the quality control unit are not in writing.
4Other quality system
Disinfectant contact time (also known as <Redacted B4> and coverage of the item being disinfected were insufficient to achieve adequate levels of disinfection .
5Quality unit oversight
The quality control unit lacks responsibility to approve and reject all procedures or specifications impacting on the identity, strength, quality and purity of drug products.
About this record
Extracted automatically from the document US FDA published on 2021-10-05. 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.
