AEI Technologies, Inc
Form 483 issued September 18, 2015 · Pittsburgh, Pennsylvania
- Inspection
- Aug 26 – Sep 18, 2015
- Investigator
- Dennis R. Hock
- Observations
- 8
- Pages
- 5
- FEI number
- 3004055954
In short: On September 18, 2015, FDA issued a Form 483 with 8 observations to AEI Technologies, Inc in Pittsburgh, Pennsylvania (FEI 3004055954) after an inspection that ran Aug 26 – Sep 18, 2015. The investigator was Dennis R. Hock. Most observations concern management controls and production & process controls; the most-cited regulation is 21 CFR 820.22 (quality audit).
At a glance
Management controls and production & process controls account for 6 of 8 observations.
Most cited: 21 CFR 820.22 (2×)
What FDA observed
Preview: the opening words of each observation- 01
Not all complaints have been adequately reviewed and evaluated to determine whether…
- 02
Procedures for corrective and preventive action…
- 0321 CFR 820.20(b)21 CFR 820
The organizational structure has not been established and maintained to ensure that devices are designed and…
- 04
Quality audits were not performed at defined intervals to determine whether the quality system activities and…
This inspection in context
Dennis R. Hock
10 documents · 2014–2024
Cites 820.30(g) (design controls) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmAEI Technologies, Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at AEI Technologies, Inc?
FDA listed 8 observations on this Form 483, mostly about management controls, production & process controls and cAPA. The most-cited regulation is 21 CFR 820.22 (quality audit). The opening words of each observation are shown on this page.
Who inspected AEI Technologies, Inc?
Dennis R. Hock is named on this Form 483, for the inspection of Aug 26 – Sep 18, 2015. Each investigator has a profile showing what they cite most.
When was AEI Technologies, Inc inspected by FDA?
The inspection ran Aug 26 – Sep 18, 2015, and the Form 483 is dated September 18, 2015.
How do I get the full Form 483 for AEI Technologies, Inc?
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.