Accupac, LLC
Form 483 issued March 31, 2016 · Mainland, Pennsylvania
- Inspection
- Mar 16 – Mar 31, 2016
- Investigator
- Edward D. McDonald
- Observations
- 5
- Pages
- 3
- FEI number
- 2518467
In short: On March 31, 2016, FDA issued a Form 483 with 5 observations to Accupac, LLC in Mainland, Pennsylvania (FEI 2518467) after an inspection that ran Mar 16 – Mar 31, 2016. The investigator was Edward D. McDonald. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Facilities & equipment and laboratory controls account for 3 of 5 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Observation 1: scanned text, readable in the full document.
- 02
SOP MF-0017, USP Purified Water Monitoring Program, requires pFI data for all sampling sites. No…
- 03
Manufacturing suite J was observed with peeling paint on the lower level ceiling. The production suite…
- 04
Observation 4: scanned text, readable in the full document.
This inspection in context
Edward D. McDonald
8 documents · 2014–2026
Cites 820.20 (management responsibility) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmAccupac, LLC 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 Accupac, LLC?
FDA listed 5 observations on this Form 483, mostly about facilities & equipment, laboratory controls and quality system. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected Accupac, LLC?
Edward D. McDonald is named on this Form 483, for the inspection of Mar 16 – Mar 31, 2016. Each investigator has a profile showing what they cite most.
When was Accupac, LLC inspected by FDA?
The inspection ran Mar 16 – Mar 31, 2016, and the Form 483 is dated March 31, 2016.
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.