Strides Shasun Limited KRS Gardens, Suragajakkanhalli
FDA inspection history across 3 sites, 2017 to 2022
- 5
- Form 483s
Every document, by year
- Form 483
2017: one Form 483; 2018: one Form 483; 2019: one Form 483; 2020: one Form 483; 2022: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2017–22Five Form 483s, at Bangalore South, India; Bengaluru, India and Bangalore, India.
- 2020The longest 483 on file: 5 observations over 17 pages at Bangalore, India.
Cited most
Across all Strides Shasun Limited KRS Gardens, Suragajakkanhalli observations on file
- 21 CFR 211.160General requirements4
- 21 CFR 211.192Production record review3
- 21 CFR 211.67Equipment cleaning and maintenance2
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.110(a)Sampling and testing of in-process materials and drug products1
The complete Strides Shasun Limited KRS Gardens, Suragajakkanhalli file.
All 5 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
15% off buying them one by one
Sites
Bengaluru, India
Three Form 483s · 2018 to 2022 · 8 observations
Latest: Form 483, Dec 9, 2022 →Bangalore, India
One Form 483 · 2020 · 5 observations
Latest: Form 483, Dec 5, 2020 →Bangalore South, India
One Form 483 · 2017 · 1 observation
Latest: Form 483, May 26, 2017 →
Documents
5 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-12-09 | 483 Form 483 | Bengaluru, India | 3 | $99 |
| 2020-12-05 | 483 Form 483 | Bangalore, India | 5 | $99 |
| 2019-05-24 | 483 Form 483 | Bengaluru, India | 4 | $99 |
| 2018-08-24 | 483 Form 483 | Bengaluru, India | 1 | $99 |
| 2017-05-26 | 483 Form 483 | Bangalore South, India | 1 | $99 |
Investigators on these documents
Andrew J. Idzior (1)Darren S. Brown (1)Jose E. Melendez (1)Lisa L. Flores (1)Pratik S. Upadhyay (1)Rafeeq Habeeb (1)Rumany C. Penn (1)Tamil Arasu (1)
FEI number 3004554612 · most recent document Dec 9, 2022
About Strides Shasun Limited KRS Gardens, Suragajakkanhalli
How many FDA Form 483s has Strides Shasun Limited KRS Gardens, Suragajakkanhalli received?
FDA Intel has 5 Form 483s on file for Strides Shasun Limited KRS Gardens, Suragajakkanhalli; the most recent is dated Dec 9, 2022.
When was Strides Shasun Limited KRS Gardens, Suragajakkanhalli last inspected by FDA?
The most recent FDA inspection document on file for Strides Shasun Limited KRS Gardens, Suragajakkanhalli is a Form 483 dated Dec 9, 2022, for the site in Bengaluru, India.
What did FDA cite at Strides Shasun Limited KRS Gardens, Suragajakkanhalli?
The regulations cited most in the observations on file for Strides Shasun Limited KRS Gardens, Suragajakkanhalli are 21 CFR 211.160 (General requirements), 4 times; 21 CFR 211.192 (Production record review), 3 times; 21 CFR 211.67 (Equipment cleaning and maintenance), 2 times.