McNeil Consumer Healthcare
Form 483 issued May 6, 2015 · Fort Washington, Pennsylvania
- Inspection
- Apr 20 – May 6, 2015
- Investigators
- James M. Mason· Thomas E. Friel
- Observations
- 1
- Pages
- 1
- FEI number
- 2510184
In short: On May 6, 2015, FDA issued a Form 483 with 1 observation to McNeil Consumer Healthcare in Fort Washington, Pennsylvania (FEI 2510184) after an inspection that ran Apr 20 – May 6, 2015. The investigators were James M. Mason and Thomas E. Friel. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
1 of 1 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.160(b)(1) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Laboratory controls do not include determination of conformance to appropriate written specifications for the acceptance of…
This inspection in context
James M. Mason
13 documents · 2011–2020
Cites 211.113 (control of microbiological contamination) 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 211.160(b)(1)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at McNeil Consumer Healthcare?
FDA listed 1 observation on this Form 483, mostly about 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?
James M. Mason and Thomas E. Friel are named on this Form 483, for the inspection of Apr 20 – May 6, 2015. Each investigator has a profile showing what they cite most.
When was McNeil Consumer Healthcare inspected by FDA?
The inspection ran Apr 20 – May 6, 2015, and the Form 483 is dated May 6, 2015.
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.