1Contamination control
You produced highly potent drugs without providing adequate cleaning of work surfaces and cleaning of utensils to prevent cross-contamination.
Inspection Record
College Pharmacy, Inc. — FDA 483 Findings
Inspectors Marcus F Yambot · Haroon VohraThe 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
You did not make adequate product evaluation and take remedial action where actionable microbial contamination was found to be present in the ISO 5 classified aseptic processing area during aseptic production.
3Training and personnel
Personnel donned gowning apparel improperly, in a way that may have caused the gowning apparel to become contaminated.
4Aseptic processing and sterility assurance
Disinfecting agents and cleaning wipes used in the ISO 5 classified aseptic processing areas were not sterile.
5Other quality system
You produced hazardous drugs without providing adequate cleaning of utensils to prevent cross-contaimination.
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.
