1Aseptic processing and sterility assurance
Inadequate aseptic techniques demonstrated by the operators who prepare and handle sterile drug products.
Inspection Record
William R. Grace M.D. P. C. — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Aseptic processing and sterility assurance
Inadequate faci lity design to prevent microbiological contamination of sterile drug products.
3Aseptic processing and sterility assurance
The cleaning, disinfecting and upkeep of the equipment used to produce and prepare sterile drug products are inadequate.
4Aseptic processing and sterility assurance
Drug products pur porting to be sterile are not tested to determine conformance to such requirements.
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.
