Shilpa Medicare Limited
FDA inspection history across 2 sites, 2020 to 2026
- 2
- Form 483s
Every document, by year
- Form 483
2020: one Form 483; 2026: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2020One Form 483, at Polepally, Jadcherla, India.
- 2020The longest 483 on file: 15 observations over 25 pages at Polepally, Jadcherla, India.
- 2026One Form 483, at Bengaluru, India.
Cited most
Across all Shilpa Medicare Limited observations on file
- 21 CFR 211.160General requirements3
- 21 CFR 211.100Written procedures; deviations2
- 21 CFR 211.192Production record review2
- 21 CFR 211.113Control of microbiological contamination1
- 21 CFR 211.170Reserve samples1
The complete Shilpa Medicare Limited 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
Bengaluru, India
One Form 483 · 2026 · 5 observations
Latest: Form 483, May 29, 2026 →Polepally, Jadcherla, India
One Form 483 · 2020 · 15 observations
Latest: Form 483, Feb 25, 2020 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2026-05-29 | 483 Form 483 | Bengaluru, India | 5 | $99 |
| 2020-02-25 | 483 Form 483 | Polepally, Jadcherla, India | 15 | $99 |
Investigators on these documents
FEI number 3018694237 · most recent document May 29, 2026
About Shilpa Medicare Limited
How many FDA Form 483s has Shilpa Medicare Limited received?
FDA Intel has 2 Form 483s on file for Shilpa Medicare Limited; the most recent is dated May 29, 2026.
When was Shilpa Medicare Limited last inspected by FDA?
The most recent FDA inspection document on file for Shilpa Medicare Limited is a Form 483 dated May 29, 2026, for the site in Bengaluru, India.
What did FDA cite at Shilpa Medicare Limited?
The regulations cited most in the observations on file for Shilpa Medicare Limited are 21 CFR 211.160 (General requirements), 3 times; 21 CFR 211.100 (Written procedures; deviations), 2 times; 21 CFR 211.192 (Production record review), 2 times.