McNeil Consumer Healthcare
Form 483 issued February 9, 2020 · Fort Washington, Pennsylvania
- Inspection
- Oct 27, 2010 – Feb 9, 2020
- Investigators
- Anita R. Michael· Joseph L. Despins· Linda M. Hoover
- Observations
- 7
- Pages
- 16
- FEI number
- 2510184
In short: On February 9, 2020, FDA issued a Form 483 with 7 observations to McNeil Consumer Healthcare in Fort Washington, Pennsylvania (FEI 2510184) after an inspection that ran Oct 27, 2010 – Feb 9, 2020. The investigators were Anita R. Michael, Joseph L. Despins, Linda M. Hoover and Temar Q. Williams. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
6 of 7 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures describing the handling of written and oral complaints related to drug products are…
- 02
Control procedures are not established which monitor the output and validate the performance of those manufacturing…
- 03
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 04
Records are not maintained so that data therein can be reviewed at least annually to evaluate…
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 7 observations on this Form 483, mostly about quality system and production. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected McNeil Consumer Healthcare?
Anita R. Michael, Joseph L. Despins, Linda M. Hoover and Temar Q. Williams are named on this Form 483, for the inspection of Oct 27, 2010 – Feb 9, 2020. Each investigator has a profile showing what they cite most.
When was McNeil Consumer Healthcare inspected by FDA?
The inspection ran Oct 27, 2010 – Feb 9, 2020, and the Form 483 is dated February 9, 2020.
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.