Alembic Pharmaceuticals Limited
FDA inspection history across 3 sites, 2016 to 2020
- 3
- Form 483s
Every document, by year
- Form 483
2016: one Form 483; 2018: one Form 483; 2020: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2016–20Three Form 483s, at Dist. Panchmahal, India; Tajpura, India and India.
- 2018The longest 483 on file: 1 observation over 6 pages at Tajpura, India.
Cited most
Across all Alembic Pharmaceuticals Limited observations on file
- 21 CFR 211.22Responsibilities of quality control unit2
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.122Materials examination and usage criteria1
- 21 CFR 211.192Production record review1
- 21 CFR 211.198Complaint files1
The complete Alembic Pharmaceuticals 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
India
One Form 483 · 2020
Latest: Form 483, Mar 13, 2020 →Tajpura, India
One Form 483 · 2018 · 1 observation
Latest: Form 483, Mar 20, 2018 →Dist. Panchmahal, India
One Form 483 · 2016 · 1 observation
Latest: Form 483, Mar 25, 2016 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2020-03-13 | 483 Form 483 | India | — | $99 |
| 2018-03-20 | 483 Form 483 | Tajpura, India | 1 | $99 |
| 2016-03-25 | 483 Form 483 | Dist. Panchmahal, India | 1 | $99 |
Investigators on these documents
Erika V. Butler (1)Jason K. Morgan (1)Jessica L. Pressley (1)Zhaoyang Meng (1)
FEI number 3004956904 · most recent document Mar 13, 2020
About Alembic Pharmaceuticals Limited
How many FDA Form 483s has Alembic Pharmaceuticals Limited received?
FDA Intel has 3 Form 483s on file for Alembic Pharmaceuticals Limited; the most recent is dated Mar 13, 2020.
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 13, 2020, for the site in 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 211.22 (Responsibilities of quality control unit), 2 times; 21 CFR 211.100 (Written procedures; deviations), 1 time; 21 CFR 211.122 (Materials examination and usage criteria), 1 time.