Alkem Laboratories Limited
FDA inspection history across 2 sites, 2015 to 2024
- 4
- Form 483s
Every document, by year
- Form 483
2015: one Form 483; 2017: one Form 483; 2020: one Form 483; 2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2015–17Two Form 483s, at Solan, India and Baddi, India.
- 2015The longest 483 on file: 3 observations over 2 pages at Solan, India.
- 2020One Form 483, at Baddi, India.
- 2024One Form 483, at Baddi, India.
Cited most
Across all Alkem Laboratories Limited observations on file
- 21 CFR 211.192Production record review2
- 21 CFR 211.166Stability testing1
- 21 CFR 211.186Master production and control records1
- 21 CFR 211.194Laboratory records1
- 21 CFR 211.63Equipment design, size, and location1
The complete Alkem Laboratories Limited file.
All 4 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
Baddi, India
Three Form 483s · 2017 to 2024 · 5 observations
Latest: Form 483, Mar 27, 2024 →Solan, India
One Form 483 · 2015 · 3 observations
Latest: Form 483, Jul 31, 2015 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-03-27 | 483 Form 483 | Baddi, India | 1 | $99 |
| 2020-02-21 | 483 Form 483 | Baddi, India | 2 | $99 |
| 2017-03-10 | 483 Form 483 | Baddi, India | 2 | $99 |
| 2015-07-31 | 483 Form 483 | Solan, India | 3 | $99 |
Investigators on these documents
Nicole E. Knowlton (3)Maria E. Estrella (1)Qin Xu (1)Yvins Dezan (1)
FEI number 3006370533 · most recent document Mar 27, 2024
About Alkem Laboratories Limited
How many FDA Form 483s has Alkem Laboratories Limited received?
FDA Intel has 4 Form 483s on file for Alkem Laboratories Limited; the most recent is dated Mar 27, 2024.
When was Alkem Laboratories Limited last inspected by FDA?
The most recent FDA inspection document on file for Alkem Laboratories Limited is a Form 483 dated Mar 27, 2024, for the site in Baddi, India.
What did FDA cite at Alkem Laboratories Limited?
The regulations cited most in the observations on file for Alkem Laboratories Limited are 21 CFR 211.192 (Production record review), 2 times; 21 CFR 211.166 (Stability testing), 1 time; 21 CFR 211.186 (Master production and control records), 1 time.