McNeil Consumer Healthcare
Form 483 issued June 4, 2009 · Fort Washington, Pennsylvania
- Inspection
- May 19 – Jun 4, 2009
- Investigators
- George Pyramides· Vlada Matusovsky
- Observations
- 6
- Pages
- 4
- FEI number
- 2510184
In short: On June 4, 2009, FDA issued a Form 483 with 6 observations to McNeil Consumer Healthcare in Fort Washington, Pennsylvania (FEI 2510184) after an inspection that ran May 19 – Jun 4, 2009. The investigators were George Pyramides and Vlada Matusovsky. Most observations concern quality system and materials.
At a glance
Quality system and materials account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
Failure to reject any lot of components that did not meet the appropriate written specifications for…
- 04
The written stability testing program is…
- 05
Procedures describing the handling of all written and oral complaints regarding a drug…
- 06
There is a failure to thoroughly review the failure of a batch or any of its…
This inspection in context
George Pyramides
1 document · 2009
Cites 211.166(a) (stability testing) 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 211.84(e)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at McNeil Consumer Healthcare?
FDA listed 6 observations on this Form 483, mostly about quality system, materials and laboratory controls. The opening words of each observation are shown on this page.
Who inspected McNeil Consumer Healthcare?
George Pyramides and Vlada Matusovsky are named on this Form 483, for the inspection of May 19 – Jun 4, 2009. Each investigator has a profile showing what they cite most.
When was McNeil Consumer Healthcare inspected by FDA?
The inspection ran May 19 – Jun 4, 2009, and the Form 483 is dated June 4, 2009.
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.