Zen Chemicals Private Limited
FDA inspection history in Dombivili, India, 2023
- 1
- Form 483
Every document, by year
- Form 483
2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2023One Form 483, at Dombivili, India.
Cited most
Across all Zen Chemicals Private Limited observations on file
- 21 CFR 211.68Automatic, mechanical, and electronic equipment2
- 21 CFR 211.192Production record review1
- 21 CFR 211.25Personnel qualifications1
- 21 CFR 211.67Equipment cleaning and maintenance1
The complete Zen Chemicals Private Limited file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Dombivili, India
One Form 483 · 2023 · 5 observations
Latest: Form 483, Mar 28, 2023 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-03-28 | 483 Form 483 | Dombivili, India | 5 | $99 |
FEI number 3015345351 · most recent document Mar 28, 2023
About Zen Chemicals Private Limited
How many FDA Form 483s has Zen Chemicals Private Limited received?
FDA Intel has 1 Form 483 on file for Zen Chemicals Private Limited; the most recent is dated Mar 28, 2023.
When was Zen Chemicals Private Limited last inspected by FDA?
The most recent FDA inspection document on file for Zen Chemicals Private Limited is a Form 483 dated Mar 28, 2023, for the site in Dombivili, India.
What did FDA cite at Zen Chemicals Private Limited?
The regulations cited most in the observations on file for Zen Chemicals Private Limited are 21 CFR 211.68 (Automatic, mechanical, and electronic equipment), 2 times; 21 CFR 211.192 (Production record review), 1 time; 21 CFR 211.25 (Personnel qualifications), 1 time.