Elementis Specialties (India) Private Limited
FDA inspection history in Panvel, India, 2024
- 1
- Form 483
Every document, by year
- Form 483
2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2024One Form 483, at Panvel, India.
Cited most
Across all Elementis Specialties (India) Private Limited observations on file
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.166Stability testing1
- 21 CFR 211.194Laboratory records1
- 21 CFR 211.68Automatic, mechanical, and electronic equipment1
The complete Elementis Specialties (India) Private Limited file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Panvel, India
One Form 483 · 2024 · 3 observations
Latest: Form 483, Sep 20, 2024 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-09-20 | 483 Form 483 | Panvel, India | 3 | $99 |
Investigators on these documents
FEI number 3025922195 · most recent document Sep 20, 2024
About Elementis Specialties (India) Private Limited
How many FDA Form 483s has Elementis Specialties (India) Private Limited received?
FDA Intel has 1 Form 483 on file for Elementis Specialties (India) Private Limited; the most recent is dated Sep 20, 2024.
When was Elementis Specialties (India) Private Limited last inspected by FDA?
The most recent FDA inspection document on file for Elementis Specialties (India) Private Limited is a Form 483 dated Sep 20, 2024, for the site in Panvel, India.
What did FDA cite at Elementis Specialties (India) Private Limited?
The regulations cited most in the observations on file for Elementis Specialties (India) Private Limited are 21 CFR 211.100 (Written procedures; deviations), 1 time; 21 CFR 211.166 (Stability testing), 1 time; 21 CFR 211.194 (Laboratory records), 1 time.