Alembic Pharmaceuticals Limited
FDA inspection history in Jarod, India, 2022 to 2024
- 2
- Form 483s
Every document, by year
- Form 483
2022: one Form 483; 2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2022–24Two Form 483s, at Jarod, India.
- 2024The longest 483 on file: 5 observations over 5 pages at Jarod, India.
Cited most
Across all Alembic Pharmaceuticals Limited observations on file
- 21 CFR 211.165(d)Testing and release for distribution2
- 21 CFR 211.67Equipment cleaning and maintenance2
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.110(a)Sampling and testing of in-process materials and drug products1
- 21 CFR 211.113Control of microbiological contamination1
The complete Alembic Pharmaceuticals 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
Jarod, India
Two Form 483s · 2022 to 2024 · 10 observations
Latest: Form 483, Nov 22, 2024 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-11-22 | 483 Form 483 | Jarod, India | 5 | $99 |
| 2022-12-16 | 483 Form 483 | Jarod, India | 5 | $99 |
Investigators on these documents
FEI number 3016088083 · most recent document Nov 22, 2024
About Alembic Pharmaceuticals Limited
How many FDA Form 483s has Alembic Pharmaceuticals Limited received?
FDA Intel has 2 Form 483s on file for Alembic Pharmaceuticals Limited; the most recent is dated Nov 22, 2024.
When was Alembic Pharmaceuticals Limited last inspected by FDA?
The most recent FDA inspection document on file for Alembic Pharmaceuticals Limited is a Form 483 dated Nov 22, 2024, for the site in Jarod, India.
What did FDA cite at Alembic Pharmaceuticals Limited?
The regulations cited most in the observations on file for Alembic Pharmaceuticals Limited are 21 CFR 211.165(d) (Testing and release for distribution), 2 times; 21 CFR 211.67 (Equipment cleaning and maintenance), 2 times; 21 CFR 211.100 (Written procedures; deviations), 1 time.