Nice-Pak Products, LLC One Nice-Pak Rd
Form 483 issued April 20, 2026 · Mooresville, Indiana
- Inspection
- Apr 14 – Apr 20, 2026
- Investigator
- Muna Algharibeh
- Observations
- 3
- Pages
- 3
- FEI number
- 1822410
In short: On April 20, 2026, FDA issued a Form 483 with 3 observations to Nice-Pak Products, LLC One Nice-Pak Rd in Mooresville, Indiana (FEI 1822410) after an inspection that ran Apr 14 – Apr 20, 2026. The investigator was Muna Algharibeh. Most observations concern facilities & equipment and production.
At a glance
2 of 3 observations on this 483 concern facilities & equipment.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils…
- 02
Written procedures, designed to prevent objectionable microorganisms in drug products not required to…
- 03
Buildings used in the manufacturing of a drug product are not maintained in a…
This inspection in context
Muna Algharibeh
15 documents · 2021–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Indiana.
The firmNice-Pak Products, LLC One Nice-Pak Rd history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Nice-Pak Products, LLC One Nice-Pak Rd?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment and production. The opening words of each observation are shown on this page.
Who inspected Nice-Pak Products, LLC One Nice-Pak Rd?
Muna Algharibeh is named on this Form 483, for the inspection of Apr 14 – Apr 20, 2026. Each investigator has a profile showing what they cite most.
When was Nice-Pak Products, LLC One Nice-Pak Rd inspected by FDA?
The inspection ran Apr 14 – Apr 20, 2026, and the Form 483 is dated April 20, 2026.
How do I get the full Form 483 for Nice-Pak Products, LLC One Nice-Pak Rd?
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.