ONESOURCE SPECIALTY PHARMA LIMITED
FDA inspection history in Doddaballapura, India, 2022 to 2025
- 3
- Form 483s
Every document, by year
- Form 483
2022: two Form 483s; 2025: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2022Two Form 483s, at Doddaballapura, India.
- 2022The longest 483 on file: 5 observations over 6 pages at Doddaballapura, India.
- 2025One Form 483, at Doddaballapura, India.
Cited most
Across all ONESOURCE SPECIALTY PHARMA LIMITED observations on file
- 21 CFR 211.113(b)Control of microbiological contamination2
- 21 CFR 820.100(a)Corrective and preventive action2
- 21 CFR 211.100(a)Written procedures; deviations1
- 21 CFR 211.194Laboratory records1
- 21 CFR 211.22Responsibilities of quality control unit1
The complete ONESOURCE SPECIALTY PHARMA LIMITED file.
All 3 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Doddaballapura, India
Three Form 483s · 2022 to 2025 · 12 observations
Latest: Form 483, Mar 28, 2025 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-03-28 | 483 Form 483 | Doddaballapura, India | 4 | $99 |
| 2022-09-01 | 483 Form 483 | Doddaballapura, India | 3 | $99 |
| 2022-07-19 | 483 Form 483 | Doddaballapura, India | 5 | $99 |
Investigators on these documents
Alan A. Rivera (1)Anastasia M. Shields (1)Joshua J. Silvestri (1)Nicole E. Knowlton (1)
FEI number 3017501030 · most recent document Mar 28, 2025
About ONESOURCE SPECIALTY PHARMA LIMITED
How many FDA Form 483s has ONESOURCE SPECIALTY PHARMA LIMITED received?
FDA Intel has 3 Form 483s on file for ONESOURCE SPECIALTY PHARMA LIMITED; the most recent is dated Mar 28, 2025.
When was ONESOURCE SPECIALTY PHARMA LIMITED last inspected by FDA?
The most recent FDA inspection document on file for ONESOURCE SPECIALTY PHARMA LIMITED is a Form 483 dated Mar 28, 2025, for the site in Doddaballapura, India.
What did FDA cite at ONESOURCE SPECIALTY PHARMA LIMITED?
The regulations cited most in the observations on file for ONESOURCE SPECIALTY PHARMA LIMITED are 21 CFR 211.113(b) (Control of microbiological contamination), 2 times; 21 CFR 820.100(a) (Corrective and preventive action), 2 times; 21 CFR 211.100(a) (Written procedures; deviations), 1 time.