1Aseptic processing and sterility assurance
Materials or supplies were not disinfected prior to entering the aseptic processing areas.
Inspection Record
McGuff Compounding Pharmacy Services, Inc. — FDA 483 Findings
Inspectors Linda F Murphy · Scott N LimThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Contamination control
You produced hazardous drugs without providing adequate cleaning of work surfaces and cleaning of utensils to prevent cross-contamination.
3Aseptic processing and sterility assurance
Personnel conducted aseptic manipulations in an area that blocked the movement of first pass air around an open unit, either before or after it was filled with sterile product.
4Equipment and facility
HEPA filters were not sealed around each perimeter to the support frame.
5Aseptic processing and sterility assurance
The use of sporicidal agents in the ISO 5 classified aseptic processing area was inadequate and infrequent.
6Equipment and facility
Your facility was designed and/or operated in a way that permits poor flow of materials.
7Material and supplier control
You used a non-pharmaceutical grade component in the formulation of a drug product.
About this record
Extracted automatically from the document US FDA published on 2020-01-07. 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.
