SOFTGEL HEALTHCARE PRIVATE LIMITED
FDA inspection history in Chengalpattu, India, 2019 to 2025
- 2
- Form 483s
Every document, by year
- Form 483
2019: one Form 483; 2025: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2019One Form 483, at Chengalpattu, India.
- 2025One Form 483, at Chengalpattu, India.
- 2025The longest 483 on file: 3 observations over 3 pages at Chengalpattu, India.
Cited most
Across all SOFTGEL HEALTHCARE PRIVATE LIMITED observations on file
- 21 CFR 211.22(d)Responsibilities of quality control unit2
- 21 CFR 211.192Production record review1
- 21 CFR 211.52Washing and toilet facilities1
- 21 CFR 211.68(b)Automatic, mechanical, and electronic equipment1
The complete SOFTGEL HEALTHCARE PRIVATE LIMITED file.
All 2 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
Chengalpattu, India
Two Form 483s · 2019 to 2025 · 5 observations
Latest: Form 483, Feb 14, 2025 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-02-14 | 483 Form 483 | Chengalpattu, India | 3 | $99 |
| 2019-02-22 | 483 Form 483 | Chengalpattu, India | 2 | $99 |
Investigators on these documents
FEI number 3006381009 · most recent document Feb 14, 2025
About SOFTGEL HEALTHCARE PRIVATE LIMITED
How many FDA Form 483s has SOFTGEL HEALTHCARE PRIVATE LIMITED received?
FDA Intel has 2 Form 483s on file for SOFTGEL HEALTHCARE PRIVATE LIMITED; the most recent is dated Feb 14, 2025.
When was SOFTGEL HEALTHCARE PRIVATE LIMITED last inspected by FDA?
The most recent FDA inspection document on file for SOFTGEL HEALTHCARE PRIVATE LIMITED is a Form 483 dated Feb 14, 2025, for the site in Chengalpattu, India.
What did FDA cite at SOFTGEL HEALTHCARE PRIVATE LIMITED?
The regulations cited most in the observations on file for SOFTGEL HEALTHCARE PRIVATE LIMITED are 21 CFR 211.22(d) (Responsibilities of quality control unit), 2 times; 21 CFR 211.192 (Production record review), 1 time; 21 CFR 211.52 (Washing and toilet facilities), 1 time.