Hetero Labs Limited, Unit-EX
Form 483 issued November 8, 2022 · Anakapalli, India
- Investigator
- Arsen Karapetyan
- Observations
- 6
- Pages
- 8
- FEI number
- 3009093782
In short: On November 8, 2022, FDA issued a Form 483 with 6 observations to Hetero Labs Limited, Unit-EX in Anakapalli, Andhra Pradesh (FEI 3009093782). The investigator was Arsen Karapetyan. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Facilities & equipment and quality system account for 5 of 6 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Observation 1: scanned text, readable in the full document.
- 02
Written procedures for sanitation and describing the cleaning methods used in cleaning buildings and…
- 03
The responsibilities and procedures applicable to the quality control unit are not in…
- 04
Observation 4: scanned text, readable in the full document.
This inspection in context
Arsen Karapetyan
43 documents · 2014–2025
Cites 211.22 (responsibilities of quality control unit) 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 6 observations on this Form 483, mostly about facilities & equipment, quality system and laboratory controls. 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?
Arsen Karapetyan 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 November 8, 2022.
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.