Alembic Pharmaceuticals Limited (Units I and II) API Division - Unit I, Village Panelav, P.O. Tajpura
FDA inspection history across 2 sites, 2025
- 2
- Form 483s
Every document, by year
- Form 483
2025: two Form 483s.
The story so far
Built from the dates and citations on the documents themselves.
- 2025Two Form 483s, at Tal. Halol, India and PANCHMAHAL, India.
- 2025The longest 483 on file: 4 observations over 7 pages at Tal. Halol, India.
Cited most
Across all Alembic Pharmaceuticals Limited (Units I and II) API Division - Unit I, Village Panelav, P.O. Tajpura observations on file
- 21 CFR 211.160General requirements4
- 21 CFR 211.192Production record review2
- 21 CFR 211.22Responsibilities of quality control unit2
- 21 CFR 211.67Equipment cleaning and maintenance2
- 21 CFR 211.166Stability testing1
The complete Alembic Pharmaceuticals Limited (Units I and II) API Division - Unit I, Village Panelav, P.O. Tajpura 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
Tal. Halol, India
One Form 483 · 2025 · 4 observations
Latest: Form 483, May 31, 2025 →PANCHMAHAL, India
One Form 483 · 2025 · 4 observations
Latest: Form 483, May 31, 2025 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-05-31 | 483 Form 483 | Tal. Halol, India | 4 | $99 |
| 2025-05-31 | 483 Form 483 | PANCHMAHAL, India | 4 | $99 |
Investigators on these documents
FEI number 3003821360 · most recent document May 31, 2025
About Alembic Pharmaceuticals Limited (Units I and II) API Division - Unit I, Village Panelav, P.O. Tajpura
How many FDA Form 483s has Alembic Pharmaceuticals Limited (Units I and II) API Division - Unit I, Village Panelav, P.O. Tajpura received?
FDA Intel has 2 Form 483s on file for Alembic Pharmaceuticals Limited (Units I and II) API Division - Unit I, Village Panelav, P.O. Tajpura; the most recent is dated May 31, 2025.
When was Alembic Pharmaceuticals Limited (Units I and II) API Division - Unit I, Village Panelav, P.O. Tajpura last inspected by FDA?
The most recent FDA inspection document on file for Alembic Pharmaceuticals Limited (Units I and II) API Division - Unit I, Village Panelav, P.O. Tajpura is a Form 483 dated May 31, 2025, for the site in Tal. Halol, India.
What did FDA cite at Alembic Pharmaceuticals Limited (Units I and II) API Division - Unit I, Village Panelav, P.O. Tajpura?
The regulations cited most in the observations on file for Alembic Pharmaceuticals Limited (Units I and II) API Division - Unit I, Village Panelav, P.O. Tajpura are 21 CFR 211.160 (General requirements), 4 times; 21 CFR 211.192 (Production record review), 2 times; 21 CFR 211.22 (Responsibilities of quality control unit), 2 times.