Valens Molecules Private Limited
Form 483 issued July 29, 2016 · Medchal, India
- Inspection
- Jul 29, 2016
- Observations
- 5
- Pages
- 2
- FEI number
- 3003802255
In short: On July 29, 2016, FDA issued a Form 483 with 5 observations to Valens Molecules Private Limited in Medchal, Telangana (FEI 3003802255) after an inspection that ran Jul 29, 2016. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Observations span 4 systems, led by quality system.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Quality investigations do include…
- 02
Equipment is not qualified for use prior to the…
- 03
Laboratory control records do…
- 04
Electronically recorded quality data is not reviewed…
This inspection in context
Questions about this 483
What did FDA find at Valens Molecules Private Limited?
FDA listed 5 observations on this Form 483, mostly about quality system, laboratory controls 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.
When was Valens Molecules Private Limited inspected by FDA?
The inspection ran Jul 29, 2016, and the Form 483 is dated July 29, 2016.
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.