Valens Molecules Private Limited
Form 483 issued April 6, 2015 · Hyderabad, India
- Inspection
- Mar 30 – Apr 6, 2015
- Investigators
- Jose Lopez Rubet· Sharon K. Thoma
- Observations
- 12
- Pages
- 9
- FEI number
- 3001329340
In short: On April 6, 2015, FDA issued a Form 483 with 12 observations to Valens Molecules Private Limited in Hyderabad, Telangana (FEI 3001329340) after an inspection that ran Mar 30 – Apr 6, 2015. The investigators were Jose Lopez Rubet and Sharon K. Thoma. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Laboratory controls and quality system account for 9 of 12 observations.
Most cited: 21 CFR 211.160 (4×)
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
The specificity of the test methods have not…
- 03
Observation 3: scanned text, readable in the full document.
- 04
Procedure describing the calibration of instruments, apparatus, gauges and recording devices are…
This inspection in context
Jose Lopez Rubet
5 documents · 2015–2019
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in India.
The firmValens Molecules Private Limited history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Valens Molecules Private Limited?
FDA listed 12 observations on this Form 483, mostly about laboratory controls, quality system and materials. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Valens Molecules Private Limited?
Jose Lopez Rubet and Sharon K. Thoma are named on this Form 483, for the inspection of Mar 30 – Apr 6, 2015. Each investigator has a profile showing what they cite most.
When was Valens Molecules Private Limited inspected by FDA?
The inspection ran Mar 30 – Apr 6, 2015, and the Form 483 is dated April 6, 2015.
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.