Nice-Pak Products LLC
Form 483 issued November 7, 2022 · Smyrna, Tennessee
- Inspection
- Oct 31 – Nov 7, 2022
- Investigators
- Clinton J. Lott· Demario L. Walls· Regan T. Harp
- Observations
- 1
- Pages
- 3
- FEI number
- 1025121
In short: On November 7, 2022, FDA issued a Form 483 with 1 observation to Nice-Pak Products LLC in Smyrna, Tennessee (FEI 1025121) after an inspection that ran Oct 31 – Nov 7, 2022. The investigators were Clinton J. Lott, Demario L. Walls and Regan T. Harp. Most observations concern quality system; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.22(d) (1×)
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit…
This inspection in context
Clinton J. Lott
10 documents · 2021–2024
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmNice-Pak Products LLC history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.22(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Nice-Pak Products LLC?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Nice-Pak Products LLC?
Clinton J. Lott, Demario L. Walls and Regan T. Harp are named on this Form 483, for the inspection of Oct 31 – Nov 7, 2022. Each investigator has a profile showing what they cite most.
When was Nice-Pak Products LLC inspected by FDA?
The inspection ran Oct 31 – Nov 7, 2022, and the Form 483 is dated November 7, 2022.
How do I get the full Form 483 for Nice-Pak Products LLC?
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