Alembic Pharmaceuticals Limited
Form 483 issued November 10, 2021 · Vadodara, India
- Inspection
- Oct 28 – Nov 10, 2021
- Investigators
- Kellia N. Hicks· Yvins Dezan
- Observations
- 10
- Pages
- 25
- FEI number
- 3015685305
In short: On November 10, 2021, FDA issued a Form 483 with 10 observations to Alembic Pharmaceuticals Limited in Vadodara, Gujarat (FEI 3015685305) after an inspection that ran Oct 28 – Nov 10, 2021. The investigators were Kellia N. Hicks and Yvins Dezan. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and quality system account for 7 of 10 observations.
Most cited: 21 CFR 211.42 (3×) · 211.192 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Control procedures are not established which monitor the output and validate the performance of those manufacturing…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be did not include adequate…
- 03
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 04
Written records are not always made of investigations into unexplained discrepancies and the failure of a…
This inspection in context
Kellia N. Hicks
28 documents · 2017–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
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 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Alembic Pharmaceuticals Limited?
FDA listed 10 observations on this Form 483, mostly about facilities & equipment, quality system and production. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Alembic Pharmaceuticals Limited?
Kellia N. Hicks and Yvins Dezan are named on this Form 483, for the inspection of Oct 28 – Nov 10, 2021. Each investigator has a profile showing what they cite most.
When was Alembic Pharmaceuticals Limited inspected by FDA?
The inspection ran Oct 28 – Nov 10, 2021, and the Form 483 is dated November 10, 2021.
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.