Alchymars ICM SM Private Limited
FDA inspection history in Alathur, India, 2018 to 2026
- 2
- Close-outs
- 1
- Warning letter
- 1
- Form 483
Every document, by year
- Warning letter
- Close-out
- Form 483
2018: one Form 483 and one close-out letter; 2023: one close-out letter; 2026: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2018One Form 483 and one close-out letter, at Alathur, India.
- 2023One close-out letter, at Alathur, India.
- 2026One warning letter, at Alathur, India.
Cited most
Across all Alchymars ICM SM Private Limited observations on file
- 21 CFR 211.68Automatic, mechanical, and electronic equipment4
- 21 CFR 211.160General requirements3
- 21 CFR 211.67Equipment cleaning and maintenance3
- 21 CFR 211.194Laboratory records2
- 21 CFR 211.101Charge-in of components1
The complete Alchymars ICM SM Private 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
Alathur, India
Two close-out letters, one warning letter and one Form 483 · 2018 to 2026 · 11 observations
Latest: Warning letter, May 21, 2026 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2026-05-21 | Warning letter Warning letter | Alathur, India | — | $99 |
| 2023-01-31 | Close-out Close-out letter | Alathur, India | — | $99 |
| 2018-10-19 | 483 Form 483 | Alathur, India | 11 | $99 |
| 2018-02-16 | Close-out Close-out letter | Alathur, India | — | $99 |
Investigators on these documents
FEI number 3005216842 · most recent document May 21, 2026
About Alchymars ICM SM Private Limited
How many FDA Form 483s has Alchymars ICM SM Private Limited received?
FDA Intel has 1 Form 483 on file for Alchymars ICM SM Private Limited; the most recent is dated Oct 19, 2018.
When was Alchymars ICM SM Private Limited last inspected by FDA?
The most recent FDA inspection document on file for Alchymars ICM SM Private Limited is a Form 483 dated Oct 19, 2018, for the site in Alathur, India.
What did FDA cite at Alchymars ICM SM Private Limited?
The regulations cited most in the observations on file for Alchymars ICM SM Private Limited are 21 CFR 211.68 (Automatic, mechanical, and electronic equipment), 4 times; 21 CFR 211.160 (General requirements), 3 times; 21 CFR 211.67 (Equipment cleaning and maintenance), 3 times.
Has Alchymars ICM SM Private Limited received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Alchymars ICM SM Private Limited; the most recent is dated May 21, 2026.