Hetero Labs Limited
Form 483 issued March 23, 2018 · Hyderabad, India
- Inspection
- Mar 19 – Mar 23, 2018
- Investigator
- Rita K. Kabaso
- Observations
- 3
- Pages
- 3
- FEI number
- 3005406526
In short: On March 23, 2018, FDA issued a Form 483 with 3 observations to Hetero Labs Limited in Hyderabad, Telangana (FEI 3005406526) after an inspection that ran Mar 19 – Mar 23, 2018. The investigator was Rita K. Kabaso. Most observations concern laboratory controls and production.
At a glance
2 of 3 observations on this 483 concern laboratory controls.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Master production and control records lack complete manufacturing and control instructions and…
- 02
The written stability testing…
- 03
Laboratory records do not include complete records of any testing and standardization of laboratory reference standards…
This inspection in context
Rita K. Kabaso
18 documents · 2015–2023
Cites 211.192 (production record review) 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 211.186
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Hetero Labs Limited?
FDA listed 3 observations on this Form 483, mostly about laboratory controls and production. The opening words of each observation are shown on this page.
Who inspected Hetero Labs Limited?
Rita K. Kabaso is named on this Form 483, for the inspection of Mar 19 – Mar 23, 2018. Each investigator has a profile showing what they cite most.
When was Hetero Labs Limited inspected by FDA?
The inspection ran Mar 19 – Mar 23, 2018, and the Form 483 is dated March 23, 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.