Shilpa Medicare Limited S-20 to S-26 Pharma. Formulations SEZ; TSIIC, Green Ind. Park
FDA inspection history across 4 sites, 2017 to 2025
- 4
- Form 483s
- 1
- Close-out
Every document, by year
- Form 483
- Close-out
2017: one Form 483; 2019: one Form 483; 2020: one close-out letter; 2023: one Form 483; 2025: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2017–20Two Form 483s and one close-out letter, at Polepally, India; Jadcherla, India and Raichur, India.
- 2023–25Two Form 483s, at Jadcherla, India and Polepally, Jadcherla, India.
- 2023The longest 483 on file: 10 observations over 14 pages at Jadcherla, India.
Cited most
Across all Shilpa Medicare Limited S-20 to S-26 Pharma. Formulations SEZ; TSIIC, Green Ind. Park observations on file
- 21 CFR 211.160General requirements4
- 21 CFR 211.42Design and construction features3
- 21 CFR 211.113Control of microbiological contamination2
- 21 CFR 211.166Stability testing2
- 21 CFR 211.192Production record review2
The complete Shilpa Medicare Limited S-20 to S-26 Pharma. Formulations SEZ; TSIIC, Green Ind. Park 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
Jadcherla, India
Two Form 483s · 2019 to 2023 · 12 observations
Latest: Form 483, Nov 9, 2023 →Polepally, Jadcherla, India
One Form 483 · 2025 · 8 observations
Latest: Form 483, Nov 21, 2025 →Raichur, India
One close-out letter · 2020
Latest: Close-out, Oct 9, 2020 →Polepally, India
One Form 483 · 2017 · 3 observations
Latest: Form 483, Nov 30, 2017 →
Documents
5 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-11-21 | 483 Form 483 | Polepally, Jadcherla, India | 8 | $99 |
| 2023-11-09 | 483 Form 483 | Jadcherla, India | 10 | $99 |
| 2020-10-09 | Close-out Close-out letter | Raichur, India | — | $99 |
| 2019-09-06 | 483 Form 483 | Jadcherla, India | 2 | $99 |
| 2017-11-30 | 483 Form 483 | Polepally, India | 3 | $99 |
Investigators on these documents
Eileen A. Liu (1)Joseph A. Piechocki (1)Rajiv R. Srivastava (1)Roger F. Zabinski (1)Sandra A. Boyd (1)Sandra A. Hughes (1)Youkeun Kim (1)
FEI number 3009876430 · most recent document Nov 21, 2025
About Shilpa Medicare Limited S-20 to S-26 Pharma. Formulations SEZ; TSIIC, Green Ind. Park
How many FDA Form 483s has Shilpa Medicare Limited S-20 to S-26 Pharma. Formulations SEZ; TSIIC, Green Ind. Park received?
FDA Intel has 4 Form 483s on file for Shilpa Medicare Limited S-20 to S-26 Pharma. Formulations SEZ; TSIIC, Green Ind. Park; the most recent is dated Nov 21, 2025.
When was Shilpa Medicare Limited S-20 to S-26 Pharma. Formulations SEZ; TSIIC, Green Ind. Park last inspected by FDA?
The most recent FDA inspection document on file for Shilpa Medicare Limited S-20 to S-26 Pharma. Formulations SEZ; TSIIC, Green Ind. Park is a Form 483 dated Nov 21, 2025, for the site in Polepally, Jadcherla, India.
What did FDA cite at Shilpa Medicare Limited S-20 to S-26 Pharma. Formulations SEZ; TSIIC, Green Ind. Park?
The regulations cited most in the observations on file for Shilpa Medicare Limited S-20 to S-26 Pharma. Formulations SEZ; TSIIC, Green Ind. Park are 21 CFR 211.160 (General requirements), 4 times; 21 CFR 211.42 (Design and construction features), 3 times; 21 CFR 211.113 (Control of microbiological contamination), 2 times.