FDA Inspection
Metrex Research, LLC.Metrex Research, LLC. – FDA Inspection, May 20, 2022
Record Details
This FDA Inspection record concerns Metrex Research, LLC., with an inspection on May 20, 2022, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Metrex Research, LLC.
- Inspection Date
- May 20, 2022
- Product Type
- Drugs
View Company Profile
ID · b0c3b747-5257-4362-88b3-e3d10583752a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1169945
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
7- 21 CFR 211.122(d)Label storage access limited to authorized personnel
- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.165(b)Microbiological testing
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.84(d)(2)Establish reliability of supplier"s C of A
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Metrex Research, LLC.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| May 1, 2026 | Not classified | Detroit District Office | |
| December 19, 2018 | Not classified | Detroit District Office | |
| May 5, 2017 | Not classified | Detroit District Office | |
| June 5, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 28, 2012 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Metrex Research, LLC.
- FDA Inspection 1317148 - 2026-05-01
- FDA Inspection 1093401 - 2018-12-19
- FDA Inspection 1031074 - 2017-05-05
- FDA Inspection 881880 - 2014-06-05
- FDA Inspection 772056 - 2012-02-28
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.