Hetero Labs! united I Warehouse)
Form 483 issued September 26, 2025 · Vishakapatnam, India
- Inspection
- Sep 19 – Sep 26, 2025
- Investigators
- Constance Richard-Math· Guerlain Ulysse
- Observations
- 6
- Pages
- 8
- FEI number
- 3040501127
In short: On September 26, 2025, FDA issued a Form 483 with 6 observations to Hetero Labs! united I Warehouse) in Vishakapatnam, India (FEI 3040501127) after an inspection that ran Sep 19 – Sep 26, 2025. The investigators were Constance Richard-Math and Guerlain Ulysse. Most observations concern materials and quality system; the most-cited regulation is 21 CFR 211.80 (general requirements).
At a glance
4 of 6 observations on this 483 concern materials.
Most cited: 21 CFR 211.80 (5×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Access to the warehouse storing APIs, Intermediates, and key starting materials (KSMs) intended for the US…
- 02
Your facility is a warehouse that is undisclosed with the U.S FDA. This warehouse holds APIs…
- 03
There is no quality…
- 04
Procedures describing the warehousing of APIs, Intermediates and raw…
This inspection in context
Constance Richard-Math
1 document · 2025
Cites 211.80 (general requirements) more than any other section. Most of their documents are for sites in India.
The firmHetero Labs! united I Warehouse) history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.80
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Hetero Labs! united I Warehouse)?
FDA listed 6 observations on this Form 483, mostly about materials and quality system. The most-cited regulation is 21 CFR 211.80 (general requirements). The opening words of each observation are shown on this page.
Who inspected Hetero Labs! united I Warehouse)?
Constance Richard-Math and Guerlain Ulysse 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! united I Warehouse) 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! united I Warehouse)?
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.