OrBion Pharmaceuticals Private Limited
FDA inspection history in Sriperumbudur, India, 2023
- 1
- Form 483
Every document, by year
- Form 483
2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2023One Form 483, at Sriperumbudur, India.
Cited most
Across all OrBion Pharmaceuticals Private Limited observations on file
- 21 CFR 211.100(a)Written procedures; deviations1
- 21 CFR 211.160(a)General requirements1
- 21 CFR 211.63Equipment design, size, and location1
The complete OrBion Pharmaceuticals Private Limited file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Sriperumbudur, India
One Form 483 · 2023 · 3 observations
Latest: Form 483, Sep 8, 2023 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-09-08 | 483 Form 483 | Sriperumbudur, India | 3 | $99 |
Investigators on these documents
FEI number 3004540907 · most recent document Sep 8, 2023
About OrBion Pharmaceuticals Private Limited
How many FDA Form 483s has OrBion Pharmaceuticals Private Limited received?
FDA Intel has 1 Form 483 on file for OrBion Pharmaceuticals Private Limited; the most recent is dated Sep 8, 2023.
When was OrBion Pharmaceuticals Private Limited last inspected by FDA?
The most recent FDA inspection document on file for OrBion Pharmaceuticals Private Limited is a Form 483 dated Sep 8, 2023, for the site in Sriperumbudur, India.
What did FDA cite at OrBion Pharmaceuticals Private Limited?
The regulations cited most in the observations on file for OrBion Pharmaceuticals Private Limited are 21 CFR 211.100(a) (Written procedures; deviations), 1 time; 21 CFR 211.160(a) (General requirements), 1 time; 21 CFR 211.63 (Equipment design, size, and location), 1 time.