FDA Intel

McNeil Consumer Healthcare

Form 483 issued December 9, 2010 · Fort Washington, Pennsylvania

Inspection
Oct 27 – Dec 9, 2010
Investigators
Anita R. Michael· Joseph L. Despins· Temar Q. Williams
Observations
7
Pages
16
FEI number
2510184

In short: On December 9, 2010, 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 – Dec 9, 2010. The investigators were Anita R. Michael, Joseph L. Despins 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.

Quality system6
Production1

Most cited: 21 CFR 211.192 (3×)

What FDA observed

Preview: the opening words of each observation
  1. 01
    21 CFR 211.198(a)

    Procedures describing the handling of written and oral complaints related to drug products are…

  2. 02
    21 CFR 211.110(a)

    Control procedures are not established which monitor the output and validate the performance of those manufacturing…

  3. 03
    21 CFR 211.192

    There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…

  4. 04
    21 CFR 211.180(e)

    Records are not maintained so that data therein can be reviewed at least annually to evaluate…

3 more observations

Plus the full detail behind each one, exactly as FDA wrote it.

Get the full 483

This inspection in context

The investigator

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 firm

McNeil Consumer Healthcare history

All 17 documents on file for this site, in date order, with what was cited at each inspection.

Similar 483s

Other 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 and Temar Q. Williams are named on this Form 483, for the inspection of Oct 27 – Dec 9, 2010. Each investigator has a profile showing what they cite most.

When was McNeil Consumer Healthcare inspected by FDA?

The inspection ran Oct 27 – Dec 9, 2010, and the Form 483 is dated December 9, 2010.

How do I get the full Form 483 for McNeil Consumer Healthcare?

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