OneSource Specialty Pharma Limited
Form 483 issued February 14, 2019 · Bengaluru, India
- Inspection
- Feb 6 – Feb 14, 2019
- Investigators
- Bijoy Panicker· Nicholas Violand
- Observations
- 1
- Pages
- 2
- FEI number
- 3005652193
In short: On February 14, 2019, FDA issued a Form 483 with 1 observation to OneSource Specialty Pharma Limited in Bengaluru, Karnataka (FEI 3005652193) after an inspection that ran Feb 6 – Feb 14, 2019. The investigators were Bijoy Panicker and Nicholas Violand. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.63 (equipment design, size, and location).
At a glance
1 of 1 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.63 (1×)
What FDA observed
Preview: the opening words of each observation- 01
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
This inspection in context
Bijoy Panicker
34 documents · 2017–2025
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in New York.
The firmOneSource Specialty Pharma 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 211.63
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at OneSource Specialty Pharma Limited?
FDA listed 1 observation on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.63 (equipment design, size, and location). The opening words of each observation are shown on this page.
Who inspected OneSource Specialty Pharma Limited?
Bijoy Panicker and Nicholas Violand are named on this Form 483, for the inspection of Feb 6 – Feb 14, 2019. Each investigator has a profile showing what they cite most.
When was OneSource Specialty Pharma Limited inspected by FDA?
The inspection ran Feb 6 – Feb 14, 2019, and the Form 483 is dated February 14, 2019.
How do I get the full Form 483 for OneSource Specialty Pharma 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.