Onesource Specialty Pharma Limited
Form 483 issued December 20, 2019 · Bengaluru, India
- Inspection
- Dec 12 – Dec 20, 2019
- Investigator
- Jose Velez
- Observations
- 1
- Pages
- 6
- FEI number
- 3003813519
In short: On December 20, 2019, FDA issued a Form 483 with 1 observation to Onesource Specialty Pharma Limited in Bengaluru, Karnataka (FEI 3003813519) after an inspection that ran Dec 12 – Dec 20, 2019. The investigator was Jose Velez. Most observations concern quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (1×)
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
This inspection in context
Jose Velez
24 documents · 2014–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Puerto Rico.
The firmOnesource Specialty Pharma Limited history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
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 quality system. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Onesource Specialty Pharma Limited?
Jose Velez is named on this Form 483, for the inspection of Dec 12 – Dec 20, 2019. Each investigator has a profile showing what they cite most.
When was Onesource Specialty Pharma Limited inspected by FDA?
The inspection ran Dec 12 – Dec 20, 2019, and the Form 483 is dated December 20, 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.