Elysium Pharmaceuticals Limited
Form 483 issued January 16, 2023 · VADODARA, India
- Inspection
- Jan 9 – Jan 16, 2023
- Investigators
- Alan P. Kurtzberg· Santos E. Camara
- Observations
- 5
- Pages
- 3
- FEI number
- 3005183272
In short: On January 16, 2023, FDA issued a Form 483 with 5 observations to Elysium Pharmaceuticals Limited in VADODARA, Gujarat (FEI 3005183272) after an inspection that ran Jan 9 – Jan 16, 2023. The investigators were Alan P. Kurtzberg and Santos E. Camara. Most observations concern laboratory controls and facilities & equipment.
At a glance
Laboratory controls and facilities & equipment account for 4 of 5 observations.
What FDA observed
Preview: the opening words of each observation- 01
Deviations from written test procedures are…
- 02
Laboratory records do not include complete data derived from all tests, examinations and assay necessary to…
- 03
The plumbing system contains defects that could contribute to the…
- 04
Procedures for the cleaning and maintenance of equipment are deficient regarding inspection of the equipment for…
This inspection in context
Alan P. Kurtzberg
24 documents · 2015–2023
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in India.
The firmElysium Pharmaceuticals Limited history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.160(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Elysium Pharmaceuticals Limited?
FDA listed 5 observations on this Form 483, mostly about laboratory controls, facilities & equipment and production. The opening words of each observation are shown on this page.
Who inspected Elysium Pharmaceuticals Limited?
Alan P. Kurtzberg and Santos E. Camara are named on this Form 483, for the inspection of Jan 9 – Jan 16, 2023. Each investigator has a profile showing what they cite most.
When was Elysium Pharmaceuticals Limited inspected by FDA?
The inspection ran Jan 9 – Jan 16, 2023, and the Form 483 is dated January 16, 2023.
How do I get the full Form 483 for Elysium 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.