Teva Puerto Rico LLC
FDA inspection history in Fajardo, Puerto Rico, 2015 to 2022
- 3
- Form 483s
Every document, by year
- Form 483
2015: one Form 483; 2017: one Form 483; 2022: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2015–17Two Form 483s, at Fajardo, Puerto Rico.
- 2022One Form 483, at Fajardo, Puerto Rico.
- 2022The longest 483 on file: 2 observations over 3 pages at Fajardo, Puerto Rico.
Cited most
Across all Teva Puerto Rico observations on file
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.113Control of microbiological contamination1
- 21 CFR 211.165Testing and release for distribution1
- 21 CFR 211.186(b)(9)Master production and control records1
- 21 CFR 211.192Production record review1
The complete Teva Puerto Rico 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
Fajardo, Puerto Rico
Three Form 483s · 2015 to 2022 · 6 observations
Latest: Form 483, Nov 23, 2022 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-11-23 | 483 Form 483 | Fajardo, Puerto Rico | 2 | $99 |
| 2017-03-03 | 483 Form 483 | Fajardo, Puerto Rico | 2 | $99 |
| 2015-03-06 | 483 Form 483 | Fajardo, Puerto Rico | 2 | $99 |
Investigators on these documents
Ariel Cruz Figueroa (1)Cassandra L. Abellard (1)Jose E. Melendez (1)Libia M. Lugo (1)
FEI number 2619635 · most recent document Nov 23, 2022
About Teva Puerto Rico LLC
How many FDA Form 483s has Teva Puerto Rico LLC received?
FDA Intel has 3 Form 483s on file for Teva Puerto Rico LLC; the most recent is dated Nov 23, 2022.
When was Teva Puerto Rico LLC last inspected by FDA?
The most recent FDA inspection document on file for Teva Puerto Rico LLC is a Form 483 dated Nov 23, 2022, for the site in Fajardo, Puerto Rico.
What did FDA cite at Teva Puerto Rico LLC?
The regulations cited most in the observations on file for Teva Puerto Rico LLC are 21 CFR 211.100 (Written procedures; deviations), 1 time; 21 CFR 211.113 (Control of microbiological contamination), 1 time; 21 CFR 211.165 (Testing and release for distribution), 1 time.