Hetero Labs Limited
Form 483 issued August 28, 2014 · N. Narasapuram, India
- Investigator
- Panu Patel
- Observations
- 2
- Pages
- 1
- FEI number
- 3011002833
In short: On August 28, 2014, FDA issued a Form 483 with 2 observations to Hetero Labs Limited in N. Narasapuram, Andhra Pradesh (FEI 3011002833). The investigator was Panu Patel. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
Facilities & equipment and laboratory controls account for 2 of 2 observations.
Most cited: 21 CFR 211.68 (1×) · 211.165 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Appropriate controls are not established on computerized systems in…
- 02
The accuracy, sensitivity, specificity and reproducibility of HPLC test methods have not…
This inspection in context
Panu Patel
1 document · 2014
Cites 211.165 (testing and release for distribution) more than any other section. Most of their documents are for sites in India.
The firmHetero Labs Limited history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.68
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Hetero Labs Limited?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment and laboratory controls. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected Hetero Labs Limited?
Panu Patel is named on this Form 483. Each investigator has a profile showing what they cite most.
When was Hetero Labs Limited inspected by FDA?
This Form 483 is dated August 28, 2014.
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.