Alembic Pharmaceuticals Limited
Form 483 issued February 6, 2021 · Vadodara, India
- Inspection
- Jan 28 – Feb 6, 2021
- Investigators
- Dipesh K. Shah· Rita K. Kabaso
- Observations
- 5
- Pages
- 12
- FEI number
- 3015685305
In short: On February 6, 2021, FDA issued a Form 483 with 5 observations to Alembic Pharmaceuticals Limited in Vadodara, Gujarat (FEI 3015685305) after an inspection that ran Jan 28 – Feb 6, 2021. The investigators were Dipesh K. Shah and Rita K. Kabaso. Most observations concern facilities & equipment and production.
At a glance
3 of 5 observations on this 483 concern facilities & equipment.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions. Specifica lly, you failed…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
- 03
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 04
Equipment for adequate control over air pressure is not provided when appropriate for the manufacture, processing…
This inspection in context
Dipesh K. Shah
29 documents · 2006–2026
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 5 observations on this Form 483, mostly about facilities & equipment, production and quality system. The opening words of each observation are shown on this page.
Who inspected Alembic Pharmaceuticals Limited?
Dipesh K. Shah and Rita K. Kabaso are named on this Form 483, for the inspection of Jan 28 – Feb 6, 2021. Each investigator has a profile showing what they cite most.
When was Alembic Pharmaceuticals Limited inspected by FDA?
The inspection ran Jan 28 – Feb 6, 2021, and the Form 483 is dated February 6, 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.