1Contamination control
Personnel did not disinfect and change gloves frequently enough to prevent contamination.
Inspection Record
John L. McClellan Memorial Veterans Hospital — FDA 483 Findings
Inspectors Mina D. AhmadiThe 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
Equipment was not disinfected prior to entering the aseptic processing areas.
3Aseptic processing and sterility assurance
You had inadequate HEPA filter coverage and airflow over the area to which sterile product was exposed.
4Aseptic processing and sterility assurance
Personnel engaged in aseptic processing were observed with exposed face, neck, and ankles.
5Equipment and facility
IY our facility design allowed the influx of poor-quality air into a higher classified area.
6Other quality system
8); the condensation unit or water evaporation tray of the refrigerators located in the IS0-7 Classified areas (Please refer to
7Other quality system
7, & 8); inadequate cleaning practices (Please refer to OBSERVATIONS 1, 3, 6); non-sterile gowning, and/or exposed skin (Please refer to
8Aseptic processing and sterility assurance
IY ou did not make adequate product evaluation and take remedial action where actionable microbial contamination was fot.md o be present in an area adjacent to the ISO 5 classified aseptic processing area during aseptic production.
About this record
Extracted automatically from the document US FDA published on 2020-07-01. 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.
