Hospira Healthcare India Pvt. Ltd.
Form 483 issued April 3, 2018 · Sriperumbudur, India
- Inspection
- Mar 27 – Apr 3, 2018
- Investigators
- Ademola O. Daramola· Jose E. Melendez
- Observations
- 11
- Pages
- 32
- FEI number
- 3008386908
In short: On April 3, 2018, FDA issued a Form 483 with 11 observations to Hospira Healthcare India Pvt. Ltd. in Sriperumbudur, India (FEI 3008386908) after an inspection that ran Mar 27 – Apr 3, 2018. The investigators were Ademola O. Daramola and Jose E. Melendez. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.165 (testing and release for distribution).
At a glance
Laboratory controls and quality system account for 7 of 11 observations.
Most cited: 21 CFR 211.192 (2×)
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit…
- 02
EMPLOYEE'S) SIGNATURE Laboratory records do not include complete data derived from all tests, examinations and assay…
- 03
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 04
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
This inspection in context
Ademola O. Daramola
11 documents · 2014–2018
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Texas.
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 211.192
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 laboratory controls, quality system and production. The most-cited regulation is 21 CFR 211.165 (testing and release for distribution). The opening words of each observation are shown on this page.
Who inspected Hospira Healthcare India Pvt. Ltd.?
Ademola O. Daramola and Jose E. Melendez are named on this Form 483, for the inspection of Mar 27 – Apr 3, 2018. Each investigator has a profile showing what they cite most.
When was Hospira Healthcare India Pvt. Ltd. inspected by FDA?
The inspection ran Mar 27 – Apr 3, 2018, and the Form 483 is dated April 3, 2018.
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.