McNeil Consumer Healthcare
Form 483 issued January 12, 2006 · Fort Washington, Pennsylvania
- Inspection
- Jan 4 – Jan 12, 2006
- Investigators
- Anita R. Michael· Vlada Matusovs
- Observations
- 3
- Pages
- 2
- FEI number
- 2510184
In short: On January 12, 2006, FDA issued a Form 483 with 3 observations to McNeil Consumer Healthcare in Fort Washington, Pennsylvania (FEI 2510184) after an inspection that ran Jan 4 – Jan 12, 2006. The investigators were Anita R. Michael and Vlada Matusovs. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
2 of 3 observations on this 483 concern quality system.
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…
- 02
The responsibilities and procedures applicable to the quality control unit…
- 03
Observation 3: scanned text, readable in the full document.
This inspection in context
Anita R. Michael
18 documents · 2006–2020
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 211.192
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 and laboratory controls. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected McNeil Consumer Healthcare?
Anita R. Michael and Vlada Matusovs are named on this Form 483, for the inspection of Jan 4 – Jan 12, 2006. Each investigator has a profile showing what they cite most.
When was McNeil Consumer Healthcare inspected by FDA?
The inspection ran Jan 4 – Jan 12, 2006, and the Form 483 is dated January 12, 2006.
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.