ONESOURCE SPECIALTY PHARMA LIMITED
Form 483 issued September 1, 2022 · Doddaballapura, India
- Inspection
- Aug 29 – Sep 1, 2022
- Investigator
- Joshua J. Silvestri
- Observations
- 3
- Pages
- 5
- FEI number
- 3017501030
In short: On September 1, 2022, FDA issued a Form 483 with 3 observations to ONESOURCE SPECIALTY PHARMA LIMITED in Doddaballapura, Karnataka (FEI 3017501030) after an inspection that ran Aug 29 – Sep 1, 2022. The investigator was Joshua J. Silvestri. Most observations concern cAPA and management controls; the most-cited regulation is 21 CFR 820.100 (corrective and preventive action).
At a glance
2 of 3 observations on this 483 concern capa.
What FDA observed
Preview: the opening words of each observation- 01
Procedures for corrective and preventive action have…
- 02
Corrective and preventive action activities and/or results have…
- 03
Quality system procedures and instructions…
This inspection in context
Joshua J. Silvestri
8 documents · 2019–2025
Cites 820.100 (corrective and preventive action) more than any other section. Most of their documents are for sites in Georgia.
The firmONESOURCE SPECIALTY PHARMA LIMITED history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at ONESOURCE SPECIALTY PHARMA LIMITED?
FDA listed 3 observations on this Form 483, mostly about cAPA and management controls. The most-cited regulation is 21 CFR 820.100 (corrective and preventive action). The opening words of each observation are shown on this page.
Who inspected ONESOURCE SPECIALTY PHARMA LIMITED?
Joshua J. Silvestri is named on this Form 483, for the inspection of Aug 29 – Sep 1, 2022. Each investigator has a profile showing what they cite most.
When was ONESOURCE SPECIALTY PHARMA LIMITED inspected by FDA?
The inspection ran Aug 29 – Sep 1, 2022, and the Form 483 is dated September 1, 2022.
How do I get the full Form 483 for ONESOURCE SPECIALTY PHARMA LIMITED?
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