Nice-Pak Products LLC
Form 483 issued July 23, 2021 · Smyrna, Tennessee
- Inspection
- Jul 19 – Jul 23, 2021
- Investigators
- Clint T. Lott· June E. Riggs
- Observations
- 2
- Pages
- 4
- FEI number
- 1025121
In short: On July 23, 2021, FDA issued a Form 483 with 2 observations to Nice-Pak Products LLC in Smyrna, Tennessee (FEI 1025121) after an inspection that ran Jul 19 – Jul 23, 2021. The investigators were Clint T. Lott and June E. Riggs. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and facilities & equipment account for 2 of 2 observations.
Most cited: 21 CFR 211.192 (1×) · 211.68 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review any unexplained discrepancy or the failure of a batch…
- 02
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
This inspection in context
Clint T. Lott
1 document · 2021
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Tennessee.
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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Nice-Pak Products LLC?
FDA listed 2 observations on this Form 483, mostly about quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Nice-Pak Products LLC?
Clint T. Lott and June E. Riggs are named on this Form 483, for the inspection of Jul 19 – Jul 23, 2021. Each investigator has a profile showing what they cite most.
When was Nice-Pak Products LLC inspected by FDA?
The inspection ran Jul 19 – Jul 23, 2021, and the Form 483 is dated July 23, 2021.
How do I get the full Form 483 for Nice-Pak Products LLC?
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.