Valens Molecules Private Limited

FDA inspection history in Hyderabad, India, 2013 to 2024

2
Form 483s
1
Warning letter

Every document, by year

  • Form 483
  • Warning letter

2013: one warning letter; 2015: one Form 483; 2024: one Form 483.

The story so far

Built from the dates and citations on the documents themselves.

  1. 2013–15One warning letter and one Form 483, at Hyderabad, India.
  2. 2015The longest 483 on file: 12 observations over 9 pages at Hyderabad, India.
  3. 2024One Form 483, at Hyderabad, India.

Cited most

Across all Valens Molecules Private Limited observations on file

The complete Valens Molecules Private Limited file.

All 3 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.

$297

The price of the documents, added to your cart together

Sites

Documents

3 on file, newest first
DateDocumentPrice
2024-09-13483 Form 483$99
2015-04-06483 Form 483$99
2013-08-02Warning letter Warning letter$99

Investigators on these documents

Jose Lopez Rubet (1)Sharon K. Thoma (1)

FEI number 3001329340 · most recent document Sep 13, 2024

About Valens Molecules Private Limited

How many FDA Form 483s has Valens Molecules Private Limited received?

FDA Intel has 2 Form 483s on file for Valens Molecules Private Limited; the most recent is dated Sep 13, 2024.

When was Valens Molecules Private Limited last inspected by FDA?

The most recent FDA inspection document on file for Valens Molecules Private Limited is a Form 483 dated Sep 13, 2024, for the site in Hyderabad, India.

What did FDA cite at Valens Molecules Private Limited?

The regulations cited most in the observations on file for Valens Molecules Private Limited are 21 CFR 211.160 (General requirements), 5 times; 21 CFR 211.142 (Warehousing procedures), 1 time; 21 CFR 211.165 (Testing and release for distribution), 1 time.

Has Valens Molecules Private Limited received an FDA warning letter?

Yes. FDA Intel has 1 FDA warning letter on file for Valens Molecules Private Limited; the most recent is dated Aug 2, 2013.