Biological E. Limited
FDA inspection history in Medchal, India, 2021 to 2024
- 3
- Form 483s
Every document, by year
- Form 483
2021: one Form 483; 2024: two Form 483s.
The story so far
Built from the dates and citations on the documents themselves.
- 2021One Form 483, at Medchal, India.
- 2021The longest 483 on file: 6 observations over 9 pages at Medchal, India.
- 2024Two Form 483s, at Medchal, India.
Cited most
Across all Biological E. Limited observations on file
- 21 CFR 211.113Control of microbiological contamination4
- 21 CFR 211.160General requirements3
- 21 CFR 211.192Production record review2
- 21 CFR 211.22Responsibilities of quality control unit2
- 21 CFR 211.142Warehousing procedures1
The complete Biological E. 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
Medchal, India
Three Form 483s · 2021 to 2024 · 14 observations
Latest: Form 483, Nov 12, 2024 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-11-12 | 483 Form 483 | Medchal, India | 2 | $99 |
| 2024-04-26 | 483 Form 483 | Medchal, India | 6 | $99 |
| 2021-10-08 | 483 Form 483 | Medchal, India | 6 | $99 |
Investigators on these documents
Anastasia M. Shields (1)Clinton J. Lott (1)Cynthia Jim (1)Yvins Dezan (1)
FEI number 3008377265 · most recent document Nov 12, 2024
About Biological E. Limited
How many FDA Form 483s has Biological E. Limited received?
FDA Intel has 3 Form 483s on file for Biological E. Limited; the most recent is dated Nov 12, 2024.
When was Biological E. Limited last inspected by FDA?
The most recent FDA inspection document on file for Biological E. Limited is a Form 483 dated Nov 12, 2024, for the site in Medchal, India.
What did FDA cite at Biological E. Limited?
The regulations cited most in the observations on file for Biological E. Limited are 21 CFR 211.113 (Control of microbiological contamination), 4 times; 21 CFR 211.160 (General requirements), 3 times; 21 CFR 211.192 (Production record review), 2 times.