McNeil Consumer Healthcare
Form 483 issued April 30, 2010 · Fort Washington, Pennsylvania
- Inspection
- Apr 19 – Apr 30, 2010
- Investigators
- Anita R. Michael· Matthew R. Noonan· Sharon K. Thoma
- Observations
- 20
- Pages
- 17
- FEI number
- 2510184
In short: On April 30, 2010, FDA issued a Form 483 with 20 observations to McNeil Consumer Healthcare in Fort Washington, Pennsylvania (FEI 2510184) after an inspection that ran Apr 19 – Apr 30, 2010. The investigators were Anita R. Michael, Matthew R. Noonan and Sharon K. Thoma. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Observations span 4 systems, led by quality system.
Most cited: 21 CFR 211.110(a) (2×)
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit…
- 02
There are no written procedures for production and process controls designed to assure that the drug…
- 03
Control procedures fail to include adequacy of mixing to…
- 04
Control procedures are not established which monitor the output and validate the performance of those manufacturing…
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 211.110(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at McNeil Consumer Healthcare?
FDA listed 20 observations on this Form 483, mostly about quality system, production and laboratory controls. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected McNeil Consumer Healthcare?
Anita R. Michael, Matthew R. Noonan and Sharon K. Thoma are named on this Form 483, for the inspection of Apr 19 – Apr 30, 2010. Each investigator has a profile showing what they cite most.
When was McNeil Consumer Healthcare inspected by FDA?
The inspection ran Apr 19 – Apr 30, 2010, and the Form 483 is dated April 30, 2010.
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.