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.
- 2013–15One warning letter and one Form 483, at Hyderabad, India.
- 2015The longest 483 on file: 12 observations over 9 pages at Hyderabad, India.
- 2024One Form 483, at Hyderabad, India.
Cited most
Across all Valens Molecules Private Limited observations on file
- 21 CFR 211.160General requirements5
- 21 CFR 211.142Warehousing procedures1
- 21 CFR 211.165Testing and release for distribution1
- 21 CFR 211.166Stability testing1
- 21 CFR 211.170Reserve samples1
The complete Valens Molecules Private Limited file.
All 3 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Hyderabad, India
Two Form 483s and one warning letter · 2013 to 2024 · 13 observations
Latest: Form 483, Sep 13, 2024 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-09-13 | 483 Form 483 | Hyderabad, India | 1 | $99 |
| 2015-04-06 | 483 Form 483 | Hyderabad, India | 12 | $99 |
| 2013-08-02 | Warning letter Warning letter | Hyderabad, India | — | $99 |
Investigators on these documents
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.