Element Materials Technology Ann Arbor
Form 483 issued September 9, 2022 · Ann Arbor, Michigan
- Inspection
- Sep 5 – Sep 9, 2022
- Investigators
- Alan M. Barker· Joseph A. Piechocki
- Observations
- 2
- Pages
- 4
- FEI number
- 3008808597
In short: On September 9, 2022, FDA issued a Form 483 with 2 observations to Element Materials Technology Ann Arbor in Ann Arbor, Michigan (FEI 3008808597) after an inspection that ran Sep 5 – Sep 9, 2022. The investigators were Alan M. Barker and Joseph A. Piechocki. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
Facilities & equipment and quality system account for 2 of 2 observations.
Most cited: 21 CFR 211.68(b) (1×) · 211.22(d) (1×)
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
The responsibilities and procedures applicable to the quality control unit…
This inspection in context
Alan M. Barker
10 documents · 2021–2025
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in Michigan.
The firmElement Materials Technology Ann Arbor 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 Ann Arbor?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment and quality system. 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 Ann Arbor?
Alan M. Barker and Joseph A. Piechocki are named on this Form 483, for the inspection of Sep 5 – Sep 9, 2022. Each investigator has a profile showing what they cite most.
When was Element Materials Technology Ann Arbor inspected by FDA?
The inspection ran Sep 5 – Sep 9, 2022, and the Form 483 is dated September 9, 2022.
How do I get the full Form 483 for Element Materials Technology Ann Arbor?
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.