Metrex Research, LLC
Form 483 issued May 20, 2022 · Romulus, Michigan
- Inspection
- May 3 – May 20, 2022
- Investigator
- Brent M. Dehaan
- Observations
- 7
- Pages
- 5
- FEI number
- 1000117344
In short: On May 20, 2022, FDA issued a Form 483 with 7 observations to Metrex Research, LLC in Romulus, Michigan (FEI 1000117344) after an inspection that ran May 3 – May 20, 2022. The investigator was Brent M. Dehaan. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
Facilities & equipment and laboratory controls account for 5 of 7 observations.
What FDA observed
Preview: the opening words of each observation- 01
Each batch of drug product required to be free of objectionable microorganisms is not tested…
- 02
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, sampling plans and…
- 03
Appropriate controls are not exercised over computers or related systems to assure that changes in taster…
- 04
Observation 4: scanned text, readable in the full document.
This inspection in context
Brent M. Dehaan
4 documents · 2022
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in Michigan.
The firmMetrex Research, LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.165(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Metrex Research, LLC?
FDA listed 7 observations on this Form 483, mostly about facilities & equipment, laboratory controls and packaging & labeling. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected Metrex Research, LLC?
Brent M. Dehaan is named on this Form 483, for the inspection of May 3 – May 20, 2022. Each investigator has a profile showing what they cite most.
When was Metrex Research, LLC inspected by FDA?
The inspection ran May 3 – May 20, 2022, and the Form 483 is dated May 20, 2022.
How do I get the full Form 483 for Metrex Research, LLC?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.