Element Materials Technology Midland
Form 483 issued May 23, 2024 · Midland, Michigan
- Inspection
- May 20 – May 23, 2024
- Investigators
- Melissa M. Steiger· Nicholas J. Presto· Ramia Brzenjy
- Observations
- 3
- Pages
- 3
- FEI number
- 3004518270
In short: On May 23, 2024, FDA issued a Form 483 with 3 observations to Element Materials Technology Midland in Midland, Michigan (FEI 3004518270) after an inspection that ran May 20 – May 23, 2024. The investigators were Melissa M. Steiger, Nicholas J. Presto and Ramia Brzenjy. 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
2 of 3 observations on this 483 concern facilities & equipment.
What FDA observed
Preview: the opening words of each observation- 01
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 02
Routine calibration of mechanical equipment is not performed according to a written program designed…
- 03
Laboratory records are deficient in that they do not include the location of the data tliat…
This inspection in context
Melissa M. Steiger
7 documents · 2024–2025
Cites 211.68 (automatic, mechanical, and electronic equipment) more than any other section. Most of their documents are for sites in Michigan.
The firmElement Materials Technology Midland history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.68(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Element Materials Technology Midland?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment and laboratory controls. 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 Element Materials Technology Midland?
Melissa M. Steiger, Nicholas J. Presto and Ramia Brzenjy are named on this Form 483, for the inspection of May 20 – May 23, 2024. Each investigator has a profile showing what they cite most.
When was Element Materials Technology Midland inspected by FDA?
The inspection ran May 20 – May 23, 2024, and the Form 483 is dated May 23, 2024.
How do I get the full Form 483 for Element Materials Technology Midland?
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