McNeil PPC, Inc.
Form 483 issued July 7, 2008 · Parsippany, New Jersey
- Inspection
- Jul 7, 2008
- Investigator
- Erin D. McCaffery
- Observations
- 6
- Pages
- 5
- FEI number
- 2211583
In short: On July 7, 2008, FDA issued a Form 483 with 6 observations to McNeil PPC, Inc. in Parsippany, New Jersey (FEI 2211583) after an inspection that ran Jul 7, 2008. The investigator was Erin D. McCaffery. Most observations concern cAPA and production & process controls; the most-cited regulation is 21 CFR 820.100 (corrective and preventive action).
At a glance
CAPA and production & process controls account for 4 of 6 observations.
Most cited: 21 CFR 820.100 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Complaints involving the possible failure of a device to meet any of its specifications were…
- 02
The corrective and preventive action procedures addressing the investigation of the cause ofnonconformities relating to product…
- 03
Not all data from quality data sources are analyzed to identify existing and potential causes of…
- 04
Adequate quality requirements that must be met by…
This inspection in context
Erin D. McCaffery
4 documents · 2008–2011
Cites 314.80(b) (postmarketing reporting of adverse drug experiences) more than any other section. Most of their documents are for sites in New Jersey.
The firmMcNeil PPC, Inc. history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at McNeil PPC, Inc.?
FDA listed 6 observations on this Form 483, mostly about cAPA, production & process controls and quality system. The most-cited regulation is 21 CFR 820.100 (corrective and preventive action). The opening words of each observation are shown on this page.
Who inspected McNeil PPC, Inc.?
Erin D. McCaffery is named on this Form 483, for the inspection of Jul 7, 2008. Each investigator has a profile showing what they cite most.
When was McNeil PPC, Inc. inspected by FDA?
The inspection ran Jul 7, 2008, and the Form 483 is dated July 7, 2008.
How do I get the full Form 483 for McNeil PPC, 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.