Johnson and Johnson (McNeil)
FDA inspection history in Lancaster, Pennsylvania, 2010 to 2015
- 2
- Form 483s
Every document, by year
- Form 483
2010: one Form 483; 2015: one amended 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2010One Form 483, at Lancaster, Pennsylvania.
- 2010The longest 483 on file: 12 observations over 12 pages at Lancaster, Pennsylvania.
- 2015One amended 483, at Lancaster, Pennsylvania.
Cited most
Across all Johnson and Johnson (McNeil) observations on file
- 21 CFR 211.160General requirements3
- 21 CFR 211.192Production record review2
- 21 CFR 211.67Equipment cleaning and maintenance2
- 21 CFR 211.110(a)Sampling and testing of in-process materials and drug products1
- 21 CFR 211.113Control of microbiological contamination1
The complete Johnson and Johnson (McNeil) file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Lancaster, Pennsylvania
One amended 483 and one Form 483 · 2010 to 2015 · 14 observations
Latest: Form 483, Mar 27, 2015 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2015-03-27 | Amended 483 Amended 483 | Lancaster, Pennsylvania | 2 | $99 |
| 2010-07-09 | 483 Form 483 | Lancaster, Pennsylvania | 12 | $99 |
Investigators on these documents
Anita R. Michael (1)James M. Mason (1)Rabin N. Ghoshal (1)Sharon K. Thoma (1)Thomas E. Friel (1)
FEI number 1000150647 · most recent document Mar 27, 2015
About Johnson and Johnson (McNeil)
How many FDA Form 483s has Johnson and Johnson (McNeil) received?
FDA Intel has 2 Form 483s on file for Johnson and Johnson (McNeil); the most recent is dated Mar 27, 2015.
When was Johnson and Johnson (McNeil) last inspected by FDA?
The most recent FDA inspection document on file for Johnson and Johnson (McNeil) is a Form 483 dated Mar 27, 2015, for the site in Lancaster, Pennsylvania.
What did FDA cite at Johnson and Johnson (McNeil)?
The regulations cited most in the observations on file for Johnson and Johnson (McNeil) are 21 CFR 211.160 (General requirements), 3 times; 21 CFR 211.192 (Production record review), 2 times; 21 CFR 211.67 (Equipment cleaning and maintenance), 2 times.