Strides Pharma Science Limited
FDA inspection history across 2 sites, 2019 to 2023
- 2
- Close-outs
- 2
- Form 483s
Every document, by year
- Close-out
- Form 483
2019: one close-out letter and one Form 483; 2023: one close-out letter and one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2019One close-out letter and one Form 483, at Bangalore, India and Puducherry, India.
- 2019The longest 483 on file: 8 observations over 12 pages at Puducherry, India.
- 2023One close-out letter and one Form 483, at Bangalore, India and Puducherry, India.
Cited most
Across all Strides Pharma Science Limited observations on file
- 21 CFR 211.192Production record review2
- 21 CFR 211.67Equipment cleaning and maintenance2
- 21 CFR 211.68Automatic, mechanical, and electronic equipment2
- 21 CFR 211.180General requirements1
- 21 CFR 211.186(b)(9)Master production and control records1
The complete Strides Pharma Science Limited file.
All 4 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
Bangalore, India
Two close-out letters · 2019 to 2023
Latest: Close-out, May 23, 2023 →Puducherry, India
Two Form 483s · 2019 to 2023 · 13 observations
Latest: Form 483, Feb 24, 2023 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-05-23 | Close-out Close-out letter | Bangalore, India | — | $99 |
| 2023-02-24 | 483 Form 483 | Puducherry, India | 5 | $99 |
| 2019-07-01 | Close-out Close-out letter | Bangalore, India | — | $99 |
| 2019-02-05 | 483 Form 483 | Puducherry, India | 8 | $99 |
Investigators on these documents
FEI number 3012448465 · most recent document May 23, 2023
About Strides Pharma Science Limited
How many FDA Form 483s has Strides Pharma Science Limited received?
FDA Intel has 2 Form 483s on file for Strides Pharma Science Limited; the most recent is dated Feb 24, 2023.
When was Strides Pharma Science Limited last inspected by FDA?
The most recent FDA inspection document on file for Strides Pharma Science Limited is a Form 483 dated Feb 24, 2023, for the site in Puducherry, India.
What did FDA cite at Strides Pharma Science Limited?
The regulations cited most in the observations on file for Strides Pharma Science Limited are 21 CFR 211.192 (Production record review), 2 times; 21 CFR 211.67 (Equipment cleaning and maintenance), 2 times; 21 CFR 211.68 (Automatic, mechanical, and electronic equipment), 2 times.