MEDLEY PHARMACEUTICALS LIMITED
FDA inspection history in KACHIGAM, 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 KACHIGAM, India.
Cited most
Across all MEDLEY PHARMACEUTICALS LIMITED observations on file
- 21 CFR 211.110Sampling and testing of in-process materials and drug products1
- 21 CFR 211.113Control of microbiological contamination1
- 21 CFR 211.192Production record review1
- 21 CFR 211.46Ventilation, air filtration, air heating and cooling1
- 21 CFR 211.67Equipment cleaning and maintenance1
The complete MEDLEY PHARMACEUTICALS LIMITED file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
KACHIGAM, India
One Form 483 · 2023 · 5 observations
Latest: Form 483, May 19, 2023 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-05-19 | 483 Form 483 | KACHIGAM, India | 5 | $99 |
Investigators on these documents
FEI number 3006896204 · most recent document May 19, 2023
About MEDLEY PHARMACEUTICALS LIMITED
How many FDA Form 483s has MEDLEY PHARMACEUTICALS LIMITED received?
FDA Intel has 1 Form 483 on file for MEDLEY PHARMACEUTICALS LIMITED; the most recent is dated May 19, 2023.
When was MEDLEY PHARMACEUTICALS LIMITED last inspected by FDA?
The most recent FDA inspection document on file for MEDLEY PHARMACEUTICALS LIMITED is a Form 483 dated May 19, 2023, for the site in KACHIGAM, India.
What did FDA cite at MEDLEY PHARMACEUTICALS LIMITED?
The regulations cited most in the observations on file for MEDLEY PHARMACEUTICALS LIMITED are 21 CFR 211.110 (Sampling and testing of in-process materials and drug products), 1 time; 21 CFR 211.113 (Control of microbiological contamination), 1 time; 21 CFR 211.192 (Production record review), 1 time.