Onesource Specialty Pharma Limited
FDA inspection history across 2 sites, 2018 to 2019
- 1
- Form 483
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2018: one warning letter; 2019: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2018–19One warning letter and one Form 483, at Canonsburg, Pennsylvania and Bengaluru, India.
Cited most
Across all Onesource Specialty Pharma Limited observations on file
- 21 CFR 211.192Production record review1
The complete Onesource Specialty Pharma Limited file.
All 2 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
One Form 483 · 2019 · 1 observation
Latest: Form 483, Dec 20, 2019 →Canonsburg, Pennsylvania
One warning letter · 2018
Latest: Warning letter, Nov 9, 2018 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2019-12-20 | 483 Form 483 | Bengaluru, India | 1 | $99 |
| 2018-11-09 | Warning letter Warning letter | Canonsburg, Pennsylvania | — | $99 |
Investigators on these documents
FEI number 3003813519 · most recent document Dec 20, 2019
About Onesource Specialty Pharma Limited
How many FDA Form 483s has Onesource Specialty Pharma Limited received?
FDA Intel has 1 Form 483 on file for Onesource Specialty Pharma Limited; the most recent is dated Dec 20, 2019.
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 Dec 20, 2019, 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 211.192 (Production record review), 1 time.
Has Onesource Specialty Pharma Limited received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Onesource Specialty Pharma Limited; the most recent is dated Nov 9, 2018.