PCCI, Inc.
Form 483 issued August 16, 2018 · Alexandria, Virginia
- Inspection
- Jul 31 – Aug 16, 2018
- Investigator
- James Michael Simpson
- Observations
- 1
- Pages
- 8
- FEI number
- 3004035771
In short: On August 16, 2018, FDA issued a Form 483 with 1 observation to PCCI, Inc. in Alexandria, Virginia (FEI 3004035771) after an inspection that ran Jul 31 – Aug 16, 2018. The investigator was James Michael Simpson. Most observations concern design controls; the most-cited regulation is 21 CFR 820.30 (design controls).
At a glance
1 of 1 observations on this 483 concern design controls.
Most cited: 21 CFR 820.30(i) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures for design change have…
This inspection in context
James Michael Simpson
7 documents · 2015–2018
Cites 820.30(c) (design controls) more than any other section. Most of their documents are for sites in Virginia.
The firmPCCI, Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.30(i)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at PCCI, Inc.?
FDA listed 1 observation on this Form 483, mostly about design controls. The most-cited regulation is 21 CFR 820.30 (design controls). The opening words of each observation are shown on this page.
Who inspected PCCI, Inc.?
James Michael Simpson is named on this Form 483, for the inspection of Jul 31 – Aug 16, 2018. Each investigator has a profile showing what they cite most.
When was PCCI, Inc. inspected by FDA?
The inspection ran Jul 31 – Aug 16, 2018, and the Form 483 is dated August 16, 2018.
How do I get the full Form 483 for PCCI, 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.