1Aseptic processing and sterility assurance
Use of processing aides not intended for pharmaceutical use in sterile drug production.
Inspection Record
New Vitalis Pharmacy LLC — FDA 483 Findings
Inspectors Ucheabuchi C Chudi-NwankworThe 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
Failure to conduct media fills that closely simulate aseptic production operations under the worst-case, most-challenging, and stressful conditions.
3Equipment and facility
Use of a sporicidal agent in the facility's ISO 5 areas and classified areas was lacking.
4Aseptic processing and sterility assurance
Personnel were observed conducting aseptic manipulations where the movement of "first air" in the ISO 5 area is blocked or disrupted.
5Other quality system
Failure to conduct post-use filter-integrity testing on filters used to sterilize drug products.
6Aseptic processing and sterility assurance
Smoke studies were inadequately performed under dynamic conditions.
7Other quality system
HEP A filters are not sealed around the perimeter.
8Other quality system
Use of a disinfectant in a manner insufficient to achieve adequate levels of disinfection.
9Other quality system
Use of non-sterile cleaning wipes in the ISO 5 area.
10Contamination control
Personnel infrequently sanitized gloves to prevent contamination.
11Equipment and facility
The facility design was observed to allow the influx of lesser quality air into a classified area containing higher quality air.
About this record
Extracted automatically from the document US FDA published on 2023-11-01. 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.
