ONESOURCE SPECIALTY PHARMA LIMITED
Form 483 issued March 28, 2025 · Doddaballapura, India
- Inspection
- Mar 20 – Mar 28, 2025
- Investigators
- Alan A. Rivera· Anastasia M. Shields
- Observations
- 4
- Pages
- 6
- FEI number
- 3017501030
In short: On March 28, 2025, FDA issued a Form 483 with 4 observations to ONESOURCE SPECIALTY PHARMA LIMITED in Doddaballapura, Karnataka (FEI 3017501030) after an inspection that ran Mar 20 – Mar 28, 2025. The investigators were Alan A. Rivera and Anastasia M. Shields. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
3 of 4 observations on this 483 concern production.
Most cited: 21 CFR 211.113(b) (2×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
- 02
Your firm failed to establish adequate written procedures for production and process controls designed to assure…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
- 04
Aseptic processing areas are deficient regarding the system…
This inspection in context
Alan A. Rivera
16 documents · 2022–2026
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in India.
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 211.113(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at ONESOURCE SPECIALTY PHARMA LIMITED?
FDA listed 4 observations on this Form 483, mostly about production and facilities & equipment. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected ONESOURCE SPECIALTY PHARMA LIMITED?
Alan A. Rivera and Anastasia M. Shields are named on this Form 483, for the inspection of Mar 20 – Mar 28, 2025. Each investigator has a profile showing what they cite most.
When was ONESOURCE SPECIALTY PHARMA LIMITED inspected by FDA?
The inspection ran Mar 20 – Mar 28, 2025, and the Form 483 is dated March 28, 2025.
How do I get the full Form 483 for ONESOURCE SPECIALTY PHARMA LIMITED?
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