Accupac, LLC
Form 483 issued February 14, 2017 · Lakewood, New Jersey
- Inspection
- Feb 1 – Feb 14, 2017
- Investigator
- Russell J. Glapion
- Observations
- 2
- Pages
- 2
- FEI number
- 3010166945
In short: On February 14, 2017, FDA issued a Form 483 with 2 observations to Accupac, LLC in Lakewood, New Jersey (FEI 3010166945) after an inspection that ran Feb 1 – Feb 14, 2017. The investigator was Russell J. Glapion. Most observations concern quality system and production & process controls; the most-cited regulation is 21 CFR 211.198 (complaint files).
At a glance
Quality system and production & process controls account for 2 of 2 observations.
Most cited: 21 CFR 211.198 (1×) · 820.70 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures describing the handling of written and oral complaints related to drug products are…
- 02
Process control procedures that describe any process controls necessary to ensure conformance to specifications have…
This inspection in context
Russell J. Glapion
18 documents · 2013–2021
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in New Jersey.
The firmAccupac, 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 211.198
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Accupac, LLC?
FDA listed 2 observations on this Form 483, mostly about quality system and production & process controls. The most-cited regulation is 21 CFR 211.198 (complaint files). The opening words of each observation are shown on this page.
Who inspected Accupac, LLC?
Russell J. Glapion is named on this Form 483, for the inspection of Feb 1 – Feb 14, 2017. Each investigator has a profile showing what they cite most.
When was Accupac, LLC inspected by FDA?
The inspection ran Feb 1 – Feb 14, 2017, and the Form 483 is dated February 14, 2017.
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.