1Aseptic 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.
Inspection Record
Sentara Enterprises — FDA 483 Findings
Inspectors Tekalign WondimuThe inspectors who signed the published document.Inspector lookup
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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.
3Other quality system
Lack of disinfection of supplies at each transition from areas of lower quality air to areas of higher quality air.
4Aseptic processing and sterility assurance
Personnel performed aseptic manipulations with exposed hair or skin.
5Aseptic processing and sterility assurance
Smoke studies were inadequately performed under dynamic conditions.
About this record
Extracted automatically from the document US FDA published on 2024-03-20. 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.
