Alembic Pharmaceuticals Limited
Form 483 issued August 30, 2022 · Vadodara, India
- Inspection
- Aug 18 – Aug 30, 2022
- Investigator
- Matthew B. Casale
- Observations
- 2
- Pages
- 2
- FEI number
- 3015685305
In short: On August 30, 2022, FDA issued a Form 483 with 2 observations to Alembic Pharmaceuticals Limited in Vadodara, Gujarat (FEI 3015685305) after an inspection that ran Aug 18 – Aug 30, 2022. The investigator was Matthew B. Casale. 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 2 of 2 observations.
Most cited: 21 CFR 211.42 (1×) · 211.192 (1×)
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 air supply that is filtered through high-efficiency particulate air…
- 02
Deviations from written production and process control procedures are…
This inspection in context
Matthew B. Casale
29 documents · 2015–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Ohio.
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 2 observations on this Form 483, mostly about facilities & equipment and quality system. 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?
Matthew B. Casale is named on this Form 483, for the inspection of Aug 18 – Aug 30, 2022. Each investigator has a profile showing what they cite most.
When was Alembic Pharmaceuticals Limited inspected by FDA?
The inspection ran Aug 18 – Aug 30, 2022, and the Form 483 is dated August 30, 2022.
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.