McNeil Consumer Healthcare
Form 483 issued June 7, 2004 · Fort Washington, Pennsylvania
- Inspection
- May 17 – Jun 7, 2004
- Investigator
- Susan F. Laska
- Observations
- 14
- Pages
- 6
- FEI number
- 2510184
In short: On June 7, 2004, FDA issued a Form 483 with 14 observations to McNeil Consumer Healthcare in Fort Washington, Pennsylvania (FEI 2510184) after an inspection that ran May 17 – Jun 7, 2004. The investigator was Susan F. Laska. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Observations span 4 systems, led by quality system.
Most cited: 21 CFR 211.192 (2×) · 211.170 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has…
- 02
Investigations of an unexplained discrepancy did not extend to other drug products that may have been…
- 03
Evidence of reserve drug product sample…
- 04
Reserve samples from representative sample lots or batches of drug products selected by acceptable statistical procedures…
This inspection in context
Susan F. Laska
3 documents · 2004
Cites 211.170 (reserve samples) 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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at McNeil Consumer Healthcare?
FDA listed 14 observations on this Form 483, mostly about quality system, laboratory controls and packaging & labeling. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected McNeil Consumer Healthcare?
Susan F. Laska is named on this Form 483, for the inspection of May 17 – Jun 7, 2004. Each investigator has a profile showing what they cite most.
When was McNeil Consumer Healthcare inspected by FDA?
The inspection ran May 17 – Jun 7, 2004, and the Form 483 is dated June 7, 2004.
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.