Hetero Labs Limited, Unit-EX
Form 483 issued September 26, 2025 · Narasapmam Village, India
- Inspection
- Sep 19 – Sep 26, 2025
- Investigators
- Lisa L. Flores· Pratik S. Upadhyay· Tamil Arasu
- Observations
- 6
- Pages
- 14
- FEI number
- 3009093782
In short: On September 26, 2025, FDA issued a Form 483 with 6 observations to Hetero Labs Limited, Unit-EX in Narasapmam Village, India (FEI 3009093782) after an inspection that ran Sep 19 – Sep 26, 2025. The investigators were Lisa L. Flores, Pratik S. Upadhyay and Tamil Arasu. Most observations concern quality system and materials; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Quality system and materials account for 4 of 6 observations.
Most cited: 21 CFR 211.22 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The responsibilities and procedures applicable to the quality control unit are not in…
- 02
Your firm released finished API's and intermediates intended for the US market to an offsite…
- 03
The raw materials and quantities documented in the batch production records do not support the actual…
- 04
Your Quality Unit failed…
This inspection in context
Lisa L. Flores
20 documents · 2012–2026
Cites 211.113 (control of microbiological contamination) 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 211.22
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 quality system, materials and production. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Hetero Labs Limited, Unit-EX?
Lisa L. Flores, Pratik S. Upadhyay and Tamil Arasu are named on this Form 483, for the inspection of Sep 19 – Sep 26, 2025. Each investigator has a profile showing what they cite most.
When was Hetero Labs Limited, Unit-EX inspected by FDA?
The inspection ran Sep 19 – Sep 26, 2025, and the Form 483 is dated September 26, 2025.
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.