Hetero Labs Limited Unit 1, Survey No. 10, [DA Gaddapotharem, Jinnaram Mandal
Form 483 issued September 28, 2018 · Sanga Reddy District, India
- Inspection
- Sep 17 – Sep 28, 2018
- Investigator
- Dipesh K. Shah
- Observations
- 1
- Pages
- 6
- FEI number
- 3004378446
In short: On September 28, 2018, FDA issued a Form 483 with 1 observation to Hetero Labs Limited Unit 1, Survey No. 10, [DA Gaddapotharem, Jinnaram Mandal in Sanga Reddy District, Telangana (FEI 3004378446) after an inspection that ran Sep 17 – Sep 28, 2018. The investigator was Dipesh K. Shah. Most observations concern quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The quality control unit failed…
This inspection in context
Dipesh K. Shah
29 documents · 2006–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmHetero Labs Limited Unit 1, Survey No. 10, [DA Gaddapotharem, Jinnaram Mandal history
All 4 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 Hetero Labs Limited Unit 1, Survey No. 10, [DA Gaddapotharem, Jinnaram Mandal?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Hetero Labs Limited Unit 1, Survey No. 10, [DA Gaddapotharem, Jinnaram Mandal?
Dipesh K. Shah is named on this Form 483, for the inspection of Sep 17 – Sep 28, 2018. Each investigator has a profile showing what they cite most.
When was Hetero Labs Limited Unit 1, Survey No. 10, [DA Gaddapotharem, Jinnaram Mandal inspected by FDA?
The inspection ran Sep 17 – Sep 28, 2018, and the Form 483 is dated September 28, 2018.
How do I get the full Form 483 for Hetero Labs Limited Unit 1, Survey No. 10, [DA Gaddapotharem, Jinnaram Mandal?
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.