Alembic Pharmaceuticals Limited
Form 483 issued March 24, 2023 · Vadodara, India
- Inspection
- Mar 16 – Mar 24, 2023
- Investigator
- Nicole E. Knowlton
- Observations
- 2
- Pages
- 2
- FEI number
- 3015685305
In short: On March 24, 2023, FDA issued a Form 483 with 2 observations to Alembic Pharmaceuticals Limited in Vadodara, Gujarat (FEI 3015685305) after an inspection that ran Mar 16 – Mar 24, 2023. The investigator was Nicole E. Knowlton. Most observations concern quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
2 of 2 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (1×) · 211.22(c) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Drug product production and control records, are not reviewed and approved by the quality control unit…
- 02
The quality control unit lacks responsibility to approve and reject all procedures or specifications impacting on…
This inspection in context
Nicole E. Knowlton
36 documents · 2013–2026
Cites 211.68 (automatic, mechanical, and electronic equipment) more than any other section. Most of their documents are for sites in Florida.
The firmAlembic Pharmaceuticals Limited history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Alembic Pharmaceuticals Limited?
FDA listed 2 observations on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Alembic Pharmaceuticals Limited?
Nicole E. Knowlton is named on this Form 483, for the inspection of Mar 16 – Mar 24, 2023. Each investigator has a profile showing what they cite most.
When was Alembic Pharmaceuticals Limited inspected by FDA?
The inspection ran Mar 16 – Mar 24, 2023, and the Form 483 is dated March 24, 2023.
How do I get the full Form 483 for Alembic Pharmaceuticals Limited?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.