Pfizer Ireland Pharmaceuticals Unlimited Company
FDA inspection history in Dublin, Ireland, 2018 to 2023
- 3
- Form 483s
Every document, by year
- Form 483
2018: one Form 483; 2019: one Form 483; 2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2018–19Two Form 483s, at Dublin, Ireland.
- 2018The longest 483 on file: 4 observations over 3 pages at Dublin, Ireland.
- 2023One Form 483, at Dublin, Ireland.
Cited most
Across all Pfizer Ireland Pharmaceuticals Unlimited observations on file
- 21 CFR 211.192Production record review3
- 21 CFR 211.160General requirements1
- 21 CFR 211.42Design and construction features1
- 21 CFR 211.56Sanitation1
- 21 CFR 211.67Equipment cleaning and maintenance1
The complete Pfizer Ireland Pharmaceuticals Unlimited 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
Dublin, Ireland
Three Form 483s · 2018 to 2023 · 7 observations
Latest: Form 483, May 11, 2023 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-05-11 | 483 Form 483 | Dublin, Ireland | 1 | $99 |
| 2019-11-12 | 483 Form 483 | Dublin, Ireland | 2 | $99 |
| 2018-09-18 | 483 Form 483 | Dublin, Ireland | 4 | $99 |
Investigators on these documents
FEI number 3004145594 · most recent document May 11, 2023
About Pfizer Ireland Pharmaceuticals Unlimited Company
How many FDA Form 483s has Pfizer Ireland Pharmaceuticals Unlimited Company received?
FDA Intel has 3 Form 483s on file for Pfizer Ireland Pharmaceuticals Unlimited Company; the most recent is dated May 11, 2023.
When was Pfizer Ireland Pharmaceuticals Unlimited Company last inspected by FDA?
The most recent FDA inspection document on file for Pfizer Ireland Pharmaceuticals Unlimited Company is a Form 483 dated May 11, 2023, for the site in Dublin, Ireland.
What did FDA cite at Pfizer Ireland Pharmaceuticals Unlimited Company?
The regulations cited most in the observations on file for Pfizer Ireland Pharmaceuticals Unlimited Company are 21 CFR 211.192 (Production record review), 3 times; 21 CFR 211.160 (General requirements), 1 time; 21 CFR 211.42 (Design and construction features), 1 time.