McNeil Consumer Healthcare
Form 483 issued February 19, 2008 · Fort Washington, Pennsylvania
- Inspection
- Feb 11 – Feb 19, 2008
- Investigator
- Vlada Matusovsky
- Observations
- 3
- Pages
- 3
- FEI number
- 2510184
In short: On February 19, 2008, FDA issued a Form 483 with 3 observations to McNeil Consumer Healthcare in Fort Washington, Pennsylvania (FEI 2510184) after an inspection that ran Feb 11 – Feb 19, 2008. The investigator was Vlada Matusovsky. Most observations concern quality system; the most-cited regulation is 21 CFR 211.198 (complaint files).
At a glance
2 of 3 observations on this 483 concern quality system.
Most cited: 21 CFR 211.198 (1×) · 211.192 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Complaint records are deficient in that they do not include the findings of…
- 02
Investigations of an unexplained discrepancy did not extend to other drug products that may have been…
- 03
Complaint records are deficient in that they, dO'not document the reason and the individual making the…
This inspection in context
Vlada Matusovsky
7 documents · 2002–2015
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmMcNeil Consumer Healthcare history
All 17 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 McNeil Consumer Healthcare?
FDA listed 3 observations on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.198 (complaint files). The opening words of each observation are shown on this page.
Who inspected McNeil Consumer Healthcare?
Vlada Matusovsky is named on this Form 483, for the inspection of Feb 11 – Feb 19, 2008. Each investigator has a profile showing what they cite most.
When was McNeil Consumer Healthcare inspected by FDA?
The inspection ran Feb 11 – Feb 19, 2008, and the Form 483 is dated February 19, 2008.
How do I get the full Form 483 for McNeil Consumer Healthcare?
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.