McNeil Consumer Healthcare
FDA inspection history in Fort Washington, Pennsylvania, 2000 to 2020
- 9
- Form 483s
- 8
- EIRs
Every document, by year
- Form 483
- EIR
2000: one inspection report and one Form 483; 2003: two inspection reports; 2004: one inspection report and one Form 483; 2006: one inspection report and one Form 483; 2008: one inspection report and one Form 483; 2009: one inspection report and one Form 483; 2010: two Form 483s and one inspection report; 2015: one Form 483; 2020: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2000One inspection report and one Form 483, at Fort Washington, Pennsylvania.
- 2003–10Seven inspection reports and six Form 483s, at Fort Washington, Pennsylvania.
- 2010The longest 483 on file: 20 observations over 17 pages at Fort Washington, Pennsylvania.
- 2015One Form 483, at Fort Washington, Pennsylvania.
- 2020One Form 483, at Fort Washington, Pennsylvania.
Cited most
Across all McNeil Consumer Healthcare observations on file
- 21 CFR 211.192Production record review13
- 21 CFR 211.160General requirements6
- 21 CFR 211.22Responsibilities of quality control unit6
- 21 CFR 211.198Complaint files5
- 21 CFR 211.110Sampling and testing of in-process materials and drug products4
The complete McNeil Consumer Healthcare file.
All 17 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
25% off buying them one by one
Sites
Fort Washington, Pennsylvania
Nine Form 483s and eight inspection reports · 2000 to 2020 · 64 observations
Latest: Form 483, Feb 9, 2020 →
Documents
17 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2020-02-09 | 483 Form 483 | Fort Washington, Pennsylvania | 7 | $99 |
| 2015-05-06 | 483 Form 483 | Fort Washington, Pennsylvania | 1 | $99 |
| 2010-12-09 | 483 Form 483 | Fort Washington, Pennsylvania | 7 | $99 |
| 2010-04-30 | 483 Form 483 | Fort Washington, Pennsylvania | 20 | $99 |
| 2010-02-02 | EIR EIR | Fort Washington, Pennsylvania | — | $550 |
| 2009-06-04 | EIR EIR | Fort Washington, Pennsylvania | — | $550 |
| 2009-06-04 | 483 Form 483 | Fort Washington, Pennsylvania | 6 | $99 |
| 2008-02-19 | EIR EIR | Fort Washington, Pennsylvania | — | $550 |
| 2008-02-19 | 483 Form 483 | Fort Washington, Pennsylvania | 3 | $99 |
| 2006-10-26 | EIR EIR | Fort Washington, Pennsylvania | — | $550 |
| 2006-01-12 | 483 Form 483 | Fort Washington, Pennsylvania | 3 | $99 |
| 2004-06-07 | EIR EIR | Fort Washington, Pennsylvania | — | $550 |
| 2004-06-07 | 483 Form 483 | Fort Washington, Pennsylvania | 14 | $99 |
| 2003-12-19 | EIR EIR | Fort Washington, Pennsylvania | — | $550 |
| 2003-07-22 | EIR EIR | Fort Washington, Pennsylvania | — | $550 |
| 2000-03-09 | EIR EIR | Fort Washington, Pennsylvania | — | $550 |
| 2000-03-09 | 483 Form 483 | Fort Washington, Pennsylvania | 3 | $99 |
Investigators on these documents
Vlada Matusovsky (5)Anita R. Michael (4)Linda M. Hoover (2)Joseph L. Despins (2)Susan F. Laska (2)Temar Q. Williams (2)James M. Mason (1)James P. McEvoy (1)Jeen S. Min (1)Audrey Therese T. Uy (1)Julianne C. McCullough (1)Debra J. Bennett (1)
FEI number 2510184 · most recent document Feb 9, 2020
About McNeil Consumer Healthcare
How many FDA Form 483s has McNeil Consumer Healthcare received?
FDA Intel has 9 Form 483s on file for McNeil Consumer Healthcare; the most recent is dated Feb 9, 2020.
When was McNeil Consumer Healthcare last inspected by FDA?
The most recent FDA inspection document on file for McNeil Consumer Healthcare is a Form 483 dated Feb 9, 2020, for the site in Fort Washington, Pennsylvania.
What did FDA cite at McNeil Consumer Healthcare?
The regulations cited most in the observations on file for McNeil Consumer Healthcare are 21 CFR 211.192 (Production record review), 13 times; 21 CFR 211.160 (General requirements), 6 times; 21 CFR 211.22 (Responsibilities of quality control unit), 6 times.