1Contamination control
Microbial contamination was present in the ISO 5 area and areas adjacent to production areas.
Inspection Record
Strive Pharmacy LLC — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Aseptic processing and sterility assurance
Smoke studies were inadequately performed under dynamic conditions.
3Training and personnel
Personnel donned gowning apparel improperly, in a way that may have caused the gowning apparel to become contaminated.
Similar findings at other companies
GRM selected findings from the same type of public document whose wording is close to a finding in this document. One per company.
- Victory Medical Center Pharmacy2026-09-10 · US FDASimilar to finding 2 Smoke studies were not performed under dynamic conditions.
- Richmond VA Medical Center2026-05-12 · US FDASimilar to finding 2 Smoke studies were not performed under dynamic conditions.
- Greenwich Rx2026-09-09 · US FDASimilar to finding 3 Personnel donned gowning apparel improperly, in a way that may have caused the gowning apparel to become contaminated.
- Central Alabama Veterans Health Care System2026-04-16 · US FDASimilar to finding 2 Smoke studies were inadequately performed under dynamic conditions.
A record as of the US FDA document published on 2026-11-13. Check the agency's announcements for any later corrective action, and rely on the original text. Translation and classification are machine-made.