Accupac, LLC
Form 483 issued November 18, 2021 · Lakewood, New Jersey
- Observations
- 2
- Pages
- 5
- FEI number
- 3010166945
In short: On November 18, 2021, FDA issued a Form 483 with 2 observations to Accupac, LLC in Lakewood, New Jersey (FEI 3010166945). Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Laboratory controls and quality system account for 2 of 2 observations.
Most cited: 21 CFR 211.160(a) (1×) · 211.22(d) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Deviations from written laboratory…
- 02
The responsibilities and procedures applicable to the quality control unit…
This inspection in context
Questions about this 483
What did FDA find at Accupac, LLC?
FDA listed 2 observations on this Form 483, mostly about laboratory controls and quality system. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
When was Accupac, LLC inspected by FDA?
This Form 483 is dated November 18, 2021.
How do I get the full Form 483 for Accupac, 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.