Acupac Packaging Inc.
Form 483 issued March 14, 2025 · Mahwah, New Jersey
- Inspection
- Mar 11 – Mar 14, 2025
- Observations
- 2
- Pages
- 3
- FEI number
- 2244725
In short: On March 14, 2025, FDA issued a Form 483 with 2 observations to Acupac Packaging Inc. in Mahwah, New Jersey (FEI 2244725) after an inspection that ran Mar 11 – Mar 14, 2025. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
Facilities & equipment and laboratory controls account for 2 of 2 observations.
Most cited: 21 CFR 211.68(a) (1×) · 211.194(a)(2) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Routine inspection of automatic, mechanical and electronic equipment is not performed according to a written program…
- 02
The suitability of all testing methods is not verified under…
This inspection in context
Questions about this 483
What did FDA find at Acupac Packaging Inc.?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment and laboratory controls. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
When was Acupac Packaging Inc. inspected by FDA?
The inspection ran Mar 11 – Mar 14, 2025, and the Form 483 is dated March 14, 2025.
How do I get the full Form 483 for Acupac Packaging 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.