ONESOURCE SPECIALTY PHARMA LIMITED
Form 483 issued July 19, 2022 · Doddaballapura, India
- Inspection
- Jul 11 – Jul 19, 2022
- Investigator
- Nicole E. Knowlton
- Observations
- 5
- Pages
- 6
- FEI number
- 3017501030
In short: On July 19, 2022, FDA issued a Form 483 with 5 observations to ONESOURCE SPECIALTY PHARMA LIMITED in Doddaballapura, Karnataka (FEI 3017501030) after an inspection that ran Jul 11 – Jul 19, 2022. The investigator was Nicole E. Knowlton. Most observations concern facilities & equipment and materials.
At a glance
Facilities & equipment and materials account for 3 of 5 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 02
Appropriate controls are not exercised over computers or related systems to assure that changes in taster…
- 03
Container closure systems do not provide adequate protection against foreseeable external factors in storage and use…
- 04
The responsibilities and procedures applicable to the quality control unit are not in…
This inspection in context
Nicole E. Knowlton
36 documents · 2013–2026
Cites 211.68 (automatic, mechanical, and electronic equipment) more than any other section. Most of their documents are for sites in Florida.
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 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 5 observations on this Form 483, mostly about facilities & equipment, materials and quality system. The opening words of each observation are shown on this page.
Who inspected ONESOURCE SPECIALTY PHARMA LIMITED?
Nicole E. Knowlton is named on this Form 483, for the inspection of Jul 11 – Jul 19, 2022. Each investigator has a profile showing what they cite most.
When was ONESOURCE SPECIALTY PHARMA LIMITED inspected by FDA?
The inspection ran Jul 11 – Jul 19, 2022, and the Form 483 is dated July 19, 2022.
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.