Teva Pharmaceuticals USA, Inc.
FDA inspection history in Fairfield, New Jersey, 2017 to 2022
- 2
- Form 483s
Every document, by year
- Form 483
2017: one Form 483; 2022: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2017One Form 483, at Fairfield, New Jersey.
- 2022One Form 483, at Fairfield, New Jersey.
- 2022The longest 483 on file: 3 observations over 4 pages at Fairfield, New Jersey.
Cited most
Across all Teva Pharmaceuticals USA observations on file
- 21 CFR 211.67(a)Equipment cleaning and maintenance2
- 21 CFR 211.100(b)Written procedures; deviations1
- 21 CFR 211.194(a)Laboratory records1
- 21 CFR 211.22(d)Responsibilities of quality control unit1
- 21 CFR 211.63Equipment design, size, and location1
The complete Teva Pharmaceuticals USA 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
Fairfield, New Jersey
Two Form 483s · 2017 to 2022 · 6 observations
Latest: Form 483, Nov 10, 2022 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-11-10 | 483 Form 483 | Fairfield, New Jersey | 3 | $99 |
| 2017-02-01 | 483 Form 483 | Fairfield, New Jersey | 3 | $99 |
Investigators on these documents
FEI number 2245641 · most recent document Nov 10, 2022
About Teva Pharmaceuticals USA, Inc.
How many FDA Form 483s has Teva Pharmaceuticals USA, Inc. received?
FDA Intel has 2 Form 483s on file for Teva Pharmaceuticals USA, Inc.; the most recent is dated Nov 10, 2022.
When was Teva Pharmaceuticals USA, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Teva Pharmaceuticals USA, Inc. is a Form 483 dated Nov 10, 2022, for the site in Fairfield, New Jersey.
What did FDA cite at Teva Pharmaceuticals USA, Inc.?
The regulations cited most in the observations on file for Teva Pharmaceuticals USA, Inc. are 21 CFR 211.67(a) (Equipment cleaning and maintenance), 2 times; 21 CFR 211.100(b) (Written procedures; deviations), 1 time; 21 CFR 211.194(a) (Laboratory records), 1 time.