OneSource Specialty Pharma Limited
FDA inspection history in Bengaluru, India, 2013 to 2024
- 4
- Form 483s
Every document, by year
- Form 483
2013: one Form 483; 2015: one Form 483; 2019: one Form 483; 2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2013–15Two Form 483s, at Bengaluru, India.
- 2015The longest 483 on file: 6 observations over 3 pages at Bengaluru, India.
- 2019One Form 483, at Bengaluru, India.
- 2024One Form 483, at Bengaluru, India.
Cited most
Across all OneSource Specialty Pharma Limited observations on file
- 21 CFR 211.113Control of microbiological contamination2
- 21 CFR 211.103Calculation of yield1
- 21 CFR 211.110Sampling and testing of in-process materials and drug products1
- 21 CFR 211.160General requirements1
- 21 CFR 211.182Equipment cleaning and use log1
The complete OneSource Specialty Pharma Limited file.
All 4 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
Bengaluru, India
Four Form 483s · 2013 to 2024 · 14 observations
Latest: Form 483, Nov 22, 2024 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-11-22 | 483 Form 483 | Bengaluru, India | 3 | $99 |
| 2019-02-14 | 483 Form 483 | Bengaluru, India | 1 | $99 |
| 2015-09-01 | 483 Form 483 | Bengaluru, India | 6 | $99 |
| 2013-08-21 | 483 Form 483 | Bengaluru, India | 4 | $99 |
Investigators on these documents
Anastasia M. Shields (1)Bijoy Panicker (1)Clinton J. Lott (1)Nicholas Violand (1)Regina Brown (1)
FEI number 3005652193 · most recent document Nov 22, 2024
About OneSource Specialty Pharma Limited
How many FDA Form 483s has OneSource Specialty Pharma Limited received?
FDA Intel has 4 Form 483s on file for OneSource Specialty Pharma Limited; the most recent is dated Nov 22, 2024.
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 Nov 22, 2024, for the site in Bengaluru, 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 (Control of microbiological contamination), 2 times; 21 CFR 211.103 (Calculation of yield), 1 time; 21 CFR 211.110 (Sampling and testing of in-process materials and drug products), 1 time.