McNeil Consumer Healthcare
Form 483 issued March 9, 2000 · Fort Washington, Pennsylvania
- Inspection
- Feb 9 – Mar 9, 2000
- Investigator
- Yvonne C. St Clair
- Observations
- 3
- Pages
- 2
- FEI number
- 2510184
In short: On March 9, 2000, FDA issued a Form 483 with 3 observations to McNeil Consumer Healthcare in Fort Washington, Pennsylvania (FEI 2510184) after an inspection that ran Feb 9 – Mar 9, 2000. The investigator was Yvonne C. St Clair. Most observations concern production and quality system.
At a glance
2 of 3 observations on this 483 concern production.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 02
Reconciliation records for compression batches of Motrin IB cores are unclear in that compression batches do…
- 03
Failures and deviations associated with process validation batches are not documented and…
- 04
Hold times have not been…
This inspection in context
Yvonne C. St Clair
1 document · 2000
Cites 211.111 (time limitations on production) 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 211.188
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 production and quality system. The opening words of each observation are shown on this page.
Who inspected McNeil Consumer Healthcare?
Yvonne C. St Clair is named on this Form 483, for the inspection of Feb 9 – Mar 9, 2000. Each investigator has a profile showing what they cite most.
When was McNeil Consumer Healthcare inspected by FDA?
The inspection ran Feb 9 – Mar 9, 2000, and the Form 483 is dated March 9, 2000.
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.