Hetero Labs Limited, Unit-EX
Form 483 issued May 14, 2019 · Anakapalli, India
- Investigator
- Rajiv R. Srivastava
- Observations
- 3
- Pages
- 4
- FEI number
- 3009093782
In short: On May 14, 2019, FDA issued a Form 483 with 3 observations to Hetero Labs Limited, Unit-EX in Anakapalli, Andhra Pradesh (FEI 3009093782). The investigator was Rajiv R. Srivastava. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and facilities & equipment account for 2 of 3 observations.
Most cited: 21 CFR 211.192 (1×) · 211.67 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Investigations are inadequate in that the quality unit does not evaluate all potential root causes for…
- 02
Your firm’s cleaning processes for non-dedicated equipment have not been…
- 03
You have reprocessed. using a manufacturing process…
This inspection in context
Rajiv R. Srivastava
30 documents · 2018–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmHetero Labs Limited, Unit-EX history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Hetero Labs Limited, Unit-EX?
FDA listed 3 observations on this Form 483, mostly about quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Hetero Labs Limited, Unit-EX?
Rajiv R. Srivastava is named on this Form 483. Each investigator has a profile showing what they cite most.
When was Hetero Labs Limited, Unit-EX inspected by FDA?
This Form 483 is dated May 14, 2019.
How do I get the full Form 483 for Hetero Labs Limited, Unit-EX?
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.