Valens Molecules Private Limited
Form 483 issued September 13, 2024 · Hyderabad, India
- Inspection
- Sep 9 – Sep 13, 2024
- Observations
- 1
- Pages
- 2
- FEI number
- 3001329340
In short: On September 13, 2024, FDA issued a Form 483 with 1 observation to Valens Molecules Private Limited in Hyderabad, Telangana (FEI 3001329340) after an inspection that ran Sep 9 – Sep 13, 2024. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
1 of 1 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.160 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
This inspection in context
Questions about this 483
What did FDA find at Valens Molecules Private Limited?
FDA listed 1 observation on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
When was Valens Molecules Private Limited inspected by FDA?
The inspection ran Sep 9 – Sep 13, 2024, and the Form 483 is dated September 13, 2024.
How do I get the full Form 483 for Valens Molecules Private 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.