Alembic Pharmaceuticals Limited
FDA inspection history in Vadodara, India, 2021 to 2023
- 4
- Form 483s
Every document, by year
- Form 483
2021: two Form 483s; 2022: one Form 483; 2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2021–23Four Form 483s, at Vadodara, India.
- 2021The longest 483 on file: 10 observations over 25 pages at Vadodara, India.
Cited most
Across all Alembic Pharmaceuticals Limited observations on file
- 21 CFR 211.192Production record review5
- 21 CFR 211.42Design and construction features5
- 21 CFR 211.22Responsibilities of quality control unit3
- 21 CFR 211.113Control of microbiological contamination2
- 21 CFR 211.110Sampling and testing of in-process materials and drug products1
The complete Alembic Pharmaceuticals Limited file.
All 4 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
Vadodara, India
Four Form 483s · 2021 to 2023 · 19 observations
Latest: Form 483, Mar 24, 2023 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-03-24 | 483 Form 483 | Vadodara, India | 2 | $99 |
| 2022-08-30 | 483 Form 483 | Vadodara, India | 2 | $99 |
| 2021-11-10 | 483 Form 483 | Vadodara, India | 10 | $99 |
| 2021-02-06 | 483 Form 483 | Vadodara, India | 5 | $99 |
Investigators on these documents
Dipesh K. Shah (1)Kellia N. Hicks (1)Matthew B. Casale (1)Nicole E. Knowlton (1)Rita K. Kabaso (1)Yvins Dezan (1)
FEI number 3015685305 · most recent document Mar 24, 2023
About Alembic Pharmaceuticals Limited
How many FDA Form 483s has Alembic Pharmaceuticals Limited received?
FDA Intel has 4 Form 483s on file for Alembic Pharmaceuticals Limited; the most recent is dated Mar 24, 2023.
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 Mar 24, 2023, for the site in Vadodara, 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 211.192 (Production record review), 5 times; 21 CFR 211.42 (Design and construction features), 5 times; 21 CFR 211.22 (Responsibilities of quality control unit), 3 times.