WINDLAS BIOTECH LIMITED
FDA inspection history in Dehradun, India, 2019 to 2020
- 1
- Close-out
- 1
- Form 483
Every document, by year
- Close-out
- Form 483
2019: one Form 483; 2020: one close-out letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2019–20One Form 483 and one close-out letter, at Dehradun, India.
Cited most
Across all WINDLAS BIOTECH LIMITED observations on file
- 21 CFR 211.160General requirements1
- 21 CFR 211.165Testing and release for distribution1
- 21 CFR 211.180General requirements1
- 21 CFR 211.192Production record review1
- 21 CFR 211.194Laboratory records1
The complete WINDLAS BIOTECH LIMITED file.
All 2 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
Dehradun, India
One close-out letter and one Form 483 · 2019 to 2020 · 5 observations
Latest: Close-out, Mar 10, 2020 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2020-03-10 | Close-out Close-out letter | Dehradun, India | — | $99 |
| 2019-08-30 | 483 Form 483 | Dehradun, India | 5 | $99 |
Investigators on these documents
FEI number 3005339091 · most recent document Mar 10, 2020
About WINDLAS BIOTECH LIMITED
How many FDA Form 483s has WINDLAS BIOTECH LIMITED received?
FDA Intel has 1 Form 483 on file for WINDLAS BIOTECH LIMITED; the most recent is dated Aug 30, 2019.
When was WINDLAS BIOTECH LIMITED last inspected by FDA?
The most recent FDA inspection document on file for WINDLAS BIOTECH LIMITED is a Form 483 dated Aug 30, 2019, for the site in Dehradun, India.
What did FDA cite at WINDLAS BIOTECH LIMITED?
The regulations cited most in the observations on file for WINDLAS BIOTECH LIMITED are 21 CFR 211.160 (General requirements), 1 time; 21 CFR 211.165 (Testing and release for distribution), 1 time; 21 CFR 211.180 (General requirements), 1 time.