Hetero Labs Limited
Form 483 issued October 26, 2016 · Hyderabad, India
- Inspection
- Oct 17 – Oct 26, 2016
- Investigator
- Pratik S. Upadhyay
- Observations
- 3
- Pages
- 13
- FEI number
- 3005406526
In short: On October 26, 2016, FDA issued a Form 483 with 3 observations to Hetero Labs Limited in Hyderabad, Telangana (FEI 3005406526) after an inspection that ran Oct 17 – Oct 26, 2016. The investigator was Pratik S. Upadhyay. Most observations concern laboratory controls and quality system.
At a glance
2 of 3 observations on this 483 concern laboratory controls.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
- 02
There is a failure to thoroughly review the failure of a batch or any of its…
- 03
Laboratory records are deficient in that they do not include a complete record of all…
This inspection in context
Pratik S. Upadhyay
48 documents · 2011–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmHetero Labs Limited history
All 6 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Hetero Labs Limited?
FDA listed 3 observations on this Form 483, mostly about laboratory controls and quality system. The opening words of each observation are shown on this page.
Who inspected Hetero Labs Limited?
Pratik S. Upadhyay is named on this Form 483, for the inspection of Oct 17 – Oct 26, 2016. Each investigator has a profile showing what they cite most.
When was Hetero Labs Limited inspected by FDA?
The inspection ran Oct 17 – Oct 26, 2016, and the Form 483 is dated October 26, 2016.
How do I get the full Form 483 for Hetero Labs Limited?
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.