Hetero Labs Limited
Form 483 issued July 31, 2015 · Hyderabad, India
- Inspection
- Jul 27 – Jul 31, 2015
- Investigator
- Lucas B. Leake
- Observations
- 1
- Pages
- 1
- FEI number
- 3005406526
In short: On July 31, 2015, FDA issued a Form 483 with 1 observation to Hetero Labs Limited in Hyderabad, Telangana (FEI 3005406526) after an inspection that ran Jul 27 – Jul 31, 2015. The investigator was Lucas B. Leake. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
1 of 1 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.160 (1×)
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…
This inspection in context
Lucas B. Leake
8 documents · 2012–2019
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Texas.
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 1 observation on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Hetero Labs Limited?
Lucas B. Leake is named on this Form 483, for the inspection of Jul 27 – Jul 31, 2015. Each investigator has a profile showing what they cite most.
When was Hetero Labs Limited inspected by FDA?
The inspection ran Jul 27 – Jul 31, 2015, and the Form 483 is dated July 31, 2015.
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.