Hetero Labs Limited
Form 483 issued October 26, 2018 · Hyderabad, India
- Inspection
- Oct 22 – Oct 26, 2018
- Investigator
- Yasamin Ameri
- Observations
- 2
- Pages
- 3
- FEI number
- 3005406526
In short: On October 26, 2018, FDA issued a Form 483 with 2 observations to Hetero Labs Limited in Hyderabad, Telangana (FEI 3005406526) after an inspection that ran Oct 22 – Oct 26, 2018. The investigator was Yasamin Ameri. Most observations concern production; the most-cited regulation is 21 CFR 211.110 (sampling and testing of in-process materials and drug products).
At a glance
2 of 2 observations on this 483 concern production.
Most cited: 21 CFR 211.110 (1×) · 211.186 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Control procedures are not established which monitor the output and validate the performance of those manufacturing…
- 02
Master production and control records lack a statement of theoretical yield including the maximum and minimum…
This inspection in context
Yasamin Ameri
20 documents · 2015–2022
Cites 211.68 (automatic, mechanical, and electronic equipment) 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 211.110
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 production. The most-cited regulation is 21 CFR 211.110 (sampling and testing of in-process materials and drug products). The opening words of each observation are shown on this page.
Who inspected Hetero Labs Limited?
Yasamin Ameri is named on this Form 483, for the inspection of Oct 22 – Oct 26, 2018. Each investigator has a profile showing what they cite most.
When was Hetero Labs Limited inspected by FDA?
The inspection ran Oct 22 – Oct 26, 2018, and the Form 483 is dated October 26, 2018.
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.