Hospira Healthcare India Pvt. Ltd.
FDA inspection history across 3 sites, 2016 to 2025
- 3
- Form 483s
- 1
- Close-out
- 1
- Warning letter
Every document, by year
- Form 483
- Close-out
- Warning letter
2016: one warning letter; 2018: one Form 483; 2019: one close-out letter; 2025: two Form 483s.
The story so far
Built from the dates and citations on the documents themselves.
- 2016–19One warning letter, one Form 483 and one close-out letter, at Sriperumbudur, India and New York, New York.
- 2018The longest 483 on file: 11 observations over 32 pages at Sriperumbudur, India.
- 2025Two Form 483s, at Chennai, India.
Cited most
Across all Hospira Healthcare India Pvt. observations on file
- 21 CFR 211.160General requirements6
- 21 CFR 211.42Design and construction features6
- 21 CFR 211.113Control of microbiological contamination5
- 21 CFR 211.100Written procedures; deviations2
- 21 CFR 211.165(a)Testing and release for distribution2
The complete Hospira Healthcare India Pvt. 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
Chennai, India
Two Form 483s · 2025 · 22 observations
Latest: Form 483, Nov 27, 2025 →New York, New York
One close-out letter · 2019
Latest: Close-out, Mar 4, 2019 →Sriperumbudur, India
One Form 483 · 2018 · 11 observations
Latest: Form 483, Apr 3, 2018 →
Also: one document not tied to a site.
Documents
5 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-11-27 | 483 Form 483 | Chennai, India | 11 | $99 |
| 2025-01-27 | 483 Form 483 | Chennai, India | 11 | $99 |
| 2019-03-04 | Close-out Close-out letter | New York, New York | — | $99 |
| 2018-04-03 | 483 Form 483 | Sriperumbudur, India | 11 | $99 |
| 2016-06-08 | Warning letter Warning letter | — | — | $99 |
Investigators on these documents
Jose E. Melendez (3)Alan A. Rivera (2)Angelica M. Hernandez (2)Ademola O. Daramola (1)
FEI number 3008386908 · most recent document Nov 27, 2025
About Hospira Healthcare India Pvt. Ltd.
How many FDA Form 483s has Hospira Healthcare India Pvt. Ltd. received?
FDA Intel has 3 Form 483s on file for Hospira Healthcare India Pvt. Ltd.; the most recent is dated Nov 27, 2025.
When was Hospira Healthcare India Pvt. Ltd. last inspected by FDA?
The most recent FDA inspection document on file for Hospira Healthcare India Pvt. Ltd. is a Form 483 dated Nov 27, 2025, for the site in Chennai, India.
What did FDA cite at Hospira Healthcare India Pvt. Ltd.?
The regulations cited most in the observations on file for Hospira Healthcare India Pvt. Ltd. are 21 CFR 211.160 (General requirements), 6 times; 21 CFR 211.42 (Design and construction features), 6 times; 21 CFR 211.113 (Control of microbiological contamination), 5 times.
Has Hospira Healthcare India Pvt. Ltd. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Hospira Healthcare India Pvt. Ltd.; the most recent is dated Jun 8, 2016.