FDA Inspection
Greenwich RxGreenwich Rx – FDA Inspection, Sep 9, 2026
Record Details
This FDA Inspection record concerns Greenwich Rx, with an inspection on September 9, 2026, issued by the Dallas District Office, covering human drugs.
View Company Profile
ID · 0b85edc6-fb7d-4e87-9f8d-389b1baf6b60
Inspection Facts
- Inspection number
- 1324552
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
14- FDCA 501(a)(2)(A)Components/containers/materials, endotoxin contamination
- FDCA 501(a)(2)(A)Facility design, influx of lesser quality air
- FDCA 501(a)(2)(A)Failure/inadequate, filter integrity testing
- FDCA 501(a)(2)(A)Improper gowning, contamination
- FDCA 501(a)(2)(A)Inadequate control, construction adjacent to drug production
- FDCA 501(a)(2)(A)Inadequate smoke studies
- FDCA 501(a)(2)(A)Lack of disinfection, equipment/supplies from lower to higher quality air
- FDCA 501(a)(2)(A)Media fills, failure
- FDCA 501(a)(2)(A)Microbial contamination was present, ISO 5/areas adjacent
- FDCA 501(a)(2)(A)Personnel, blocked or disrupted first air
Showing 10 of 14 citations.
Full citation text and observation details available on the Dashboard.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.