PF Consumer Healthcare B.V. (Puerto Rico Operations) LLC
FDA inspection history in Guayama, Puerto Rico, 2014 to 2021
- 3
- Form 483s
Every document, by year
- Form 483
2014: one Form 483; 2018: one Form 483; 2021: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2014One Form 483, at Guayama, Puerto Rico.
- 2018One Form 483, at Guayama, Puerto Rico.
- 2021One Form 483, at Guayama, Puerto Rico.
- 2021The longest 483 on file: 5 observations over 14 pages at Guayama, Puerto Rico.
Cited most
Across all PF Consumer Healthcare B.V. (Puerto Rico Operations) observations on file
- 21 CFR 211.160(b)General requirements2
- 21 CFR 211.192Production record review2
- 21 CFR 211.22Responsibilities of quality control unit2
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.150Distribution procedures1
The complete PF Consumer Healthcare B.V. (Puerto Rico Operations) file.
All 3 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
Guayama, Puerto Rico
Three Form 483s · 2014 to 2021 · 10 observations
Latest: Form 483, Mar 17, 2021 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2021-03-17 | 483 Form 483 | Guayama, Puerto Rico | 5 | $99 |
| 2018-08-17 | 483 Form 483 | Guayama, Puerto Rico | 2 | $99 |
| 2014-11-17 | 483 Form 483 | Guayama, Puerto Rico | 3 | $99 |
Investigators on these documents
FEI number 3007343300 · most recent document Mar 17, 2021
About PF Consumer Healthcare B.V. (Puerto Rico Operations) LLC
How many FDA Form 483s has PF Consumer Healthcare B.V. (Puerto Rico Operations) LLC received?
FDA Intel has 3 Form 483s on file for PF Consumer Healthcare B.V. (Puerto Rico Operations) LLC; the most recent is dated Mar 17, 2021.
When was PF Consumer Healthcare B.V. (Puerto Rico Operations) LLC last inspected by FDA?
The most recent FDA inspection document on file for PF Consumer Healthcare B.V. (Puerto Rico Operations) LLC is a Form 483 dated Mar 17, 2021, for the site in Guayama, Puerto Rico.
What did FDA cite at PF Consumer Healthcare B.V. (Puerto Rico Operations) LLC?
The regulations cited most in the observations on file for PF Consumer Healthcare B.V. (Puerto Rico Operations) LLC are 21 CFR 211.160(b) (General requirements), 2 times; 21 CFR 211.192 (Production record review), 2 times; 21 CFR 211.22 (Responsibilities of quality control unit), 2 times.