Hetero Labs Limited
Form 483 issued June 7, 2019 · Hyderabad, India
- Inspection
- May 30 – Jun 7, 2019
- Investigators
- Miguel A. Martinez· Rita K. Kabaso
- Observations
- 10
- Pages
- 16
- FEI number
- 3005406526
In short: On June 7, 2019, FDA issued a Form 483 with 10 observations to Hetero Labs Limited in Hyderabad, Telangana (FEI 3005406526) after an inspection that ran May 30 – Jun 7, 2019. The investigators were Miguel A. Martinez and Rita K. Kabaso. Most observations concern laboratory controls and production; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Laboratory controls and production account for 7 of 10 observations.
Most cited: 21 CFR 211.170(b) (2×)
What FDA observed
Preview: the opening words of each observation- 01
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 02
There are no written procedures for production and process controls designed to assure that the drug…
- 03
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 04
The batch production and control records are deficient in that they do not include documentation of…
This inspection in context
Miguel A. Martinez
16 documents · 2014–2026
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in Puerto Rico.
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 211.170(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Hetero Labs Limited?
FDA listed 10 observations on this Form 483, mostly about laboratory controls, production and quality system. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected Hetero Labs Limited?
Miguel A. Martinez and Rita K. Kabaso are named on this Form 483, for the inspection of May 30 – Jun 7, 2019. Each investigator has a profile showing what they cite most.
When was Hetero Labs Limited inspected by FDA?
The inspection ran May 30 – Jun 7, 2019, and the Form 483 is dated June 7, 2019.
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.