Hospira Healthcare India Pvt. Ltd.
Form 483 issued November 27, 2025 · Chennai, India
- Inspection
- Nov 27, 2025
- Investigators
- Alan A. Rivera· Angelica M. Hernandez· Jose E. Melendez
- Observations
- 11
- Pages
- 19
- FEI number
- 3008386908
In short: On November 27, 2025, FDA issued a Form 483 with 11 observations to Hospira Healthcare India Pvt. Ltd. in Chennai, Tennessee (FEI 3008386908) after an inspection that ran Nov 27, 2025. The investigators were Alan A. Rivera, Angelica M. Hernandez and Jose E. Melendez. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and production account for 9 of 11 observations.
Most cited: 21 CFR 211.42 (3×) · 211.113 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Separate or defined areas to prevent contamination or mix-ups are deficient regarding the manufacturing and processing…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 04
Established sampling plan and test…
This inspection in context
Alan A. Rivera
16 documents · 2022–2026
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in India.
The firmHospira Healthcare India Pvt. Ltd. history
All 5 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Hospira Healthcare India Pvt. Ltd.?
FDA listed 11 observations on this Form 483, mostly about facilities & equipment, production and laboratory controls. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Hospira Healthcare India Pvt. Ltd.?
Alan A. Rivera, Angelica M. Hernandez and Jose E. Melendez are named on this Form 483, for the inspection of Nov 27, 2025. Each investigator has a profile showing what they cite most.
When was Hospira Healthcare India Pvt. Ltd. inspected by FDA?
The inspection ran Nov 27, 2025, and the Form 483 is dated November 27, 2025.
How do I get the full Form 483 for Hospira Healthcare India Pvt. Ltd.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.