Alkem Laboratories Ltd
FDA inspection history across 2 sites, 2016 to 2026
- 3
- Form 483s
Every document, by year
- Form 483
2016: one Form 483; 2018: one Form 483; 2026: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2016–18Two Form 483s, at Daman, India.
- 2026One Form 483, at Daman and Diu, India.
- 2026The longest 483 on file: 7 observations over 26 pages at Daman and Diu, India.
Cited most
Across all Alkem Laboratories observations on file
- 21 CFR 211.100Written procedures; deviations2
- 21 CFR 211.192Production record review2
- 21 CFR 211.22Responsibilities of quality control unit2
- 21 CFR 211.110Sampling and testing of in-process materials and drug products1
- 21 CFR 211.188Batch production and control records1
The complete Alkem Laboratories 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
Daman, India
Two Form 483s · 2016 to 2018 · 2 observations
Latest: Form 483, Mar 27, 2018 →Daman and Diu, India
One Form 483 · 2026 · 7 observations
Latest: Form 483, May 1, 2026 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2026-05-01 | 483 Form 483 | Daman and Diu, India | 7 | $99 |
| 2018-03-27 | 483 Form 483 | Daman, India | 1 | $99 |
| 2016-09-29 | 483 Form 483 | Daman, India | 1 | $99 |
Investigators on these documents
Cheryl Clausen (1)Dipesh K. Shah (1)June P. Page (1)Kellia N. Hicks (1)Pratik S. Upadhyay (1)Tiara N. Brown-Crosen (1)Unnee Ranjan (1)
FEI number 3006370524 · most recent document May 1, 2026
About Alkem Laboratories Ltd
How many FDA Form 483s has Alkem Laboratories Ltd received?
FDA Intel has 3 Form 483s on file for Alkem Laboratories Ltd; the most recent is dated May 1, 2026.
When was Alkem Laboratories Ltd last inspected by FDA?
The most recent FDA inspection document on file for Alkem Laboratories Ltd is a Form 483 dated May 1, 2026, for the site in Daman and Diu, India.
What did FDA cite at Alkem Laboratories Ltd?
The regulations cited most in the observations on file for Alkem Laboratories Ltd are 21 CFR 211.100 (Written procedures; deviations), 2 times; 21 CFR 211.192 (Production record review), 2 times; 21 CFR 211.22 (Responsibilities of quality control unit), 2 times.