1Aseptic processing and sterility assurance
Personnel engaged in aseptic processing were observed leaving and re-entering the cleanroorn from non-classified areas without first replacing gowning apparel.
Inspection Record
Shertech Pharmacy, LLC — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Other quality system
Your firm's records are deficient in that they do not include complete documentation of all data obtained during testing to provide assurances that your product meets release specifications.
3Aseptic processing and sterility assurance
Sporicidal agents were not used in your facility's cleanrooms and/or ISO 5 classified aseptic processing area.
4Aseptic processing and sterility assurance
Personnel touched equipment or other surfaces located outside of the ISO 5 classified aseptic processing area with gloved hands and then engaged in aseptic processing without changing or sanitizing gloves.
About this record
Extracted automatically from the document US FDA published on 2019-10-21. 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.
