Medgel Private Limited
FDA inspection history in Pithampur, India, 2023
- 1
- Warning letter
- 1
- Form 483
- 1
- Close-out
Every document, by year
- Warning letter
- Form 483
- Close-out
2023: one warning letter and one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2023One warning letter and one Form 483, at Pithampur, India.
Cited most
Across all Medgel Private Limited observations on file
- 21 CFR 211.192Production record review2
- 21 CFR 211.22(a)Responsibilities of quality control unit2
- 21 CFR 211.113(a)Control of microbiological contamination1
- 21 CFR 211.142(b)Warehousing procedures1
- 21 CFR 211.160(b)General requirements1
The complete Medgel Private Limited 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
Pithampur, India
One warning letter, one Form 483 and one close-out letter · 2023 · 11 observations
Latest: Warning letter, Jul 20, 2023 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-07-20 | Warning letter Warning letter | Pithampur, India | — | $99 |
| 2023-01-27 | 483 Form 483 | Pithampur, India | 11 | $99 |
| Undated | Close-out Close-out letter | Pithampur, India | — | $99 |
Investigators on these documents
FEI number 3010165392 · most recent document Jul 20, 2023
About Medgel Private Limited
How many FDA Form 483s has Medgel Private Limited received?
FDA Intel has 1 Form 483 on file for Medgel Private Limited; the most recent is dated Jan 27, 2023.
When was Medgel Private Limited last inspected by FDA?
The most recent FDA inspection document on file for Medgel Private Limited is a Form 483 dated Jan 27, 2023, for the site in Pithampur, India.
What did FDA cite at Medgel Private Limited?
The regulations cited most in the observations on file for Medgel Private Limited are 21 CFR 211.192 (Production record review), 2 times; 21 CFR 211.22(a) (Responsibilities of quality control unit), 2 times; 21 CFR 211.113(a) (Control of microbiological contamination), 1 time.
Has Medgel Private Limited received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Medgel Private Limited; the most recent is dated Jul 20, 2023.