AURORE PHARMACEUTICALS PRIVATE LIMITED
FDA inspection history in Hyderabad, India, 2024
- 1
- Form 483
Every document, by year
- Form 483
2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2024One Form 483, at Hyderabad, India.
Cited most
Across all AURORE PHARMACEUTICALS PRIVATE LIMITED observations on file
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.166Stability testing1
- 21 CFR 211.192Production record review1
- 21 CFR 211.22Responsibilities of quality control unit1
- 21 CFR 211.58Maintenance1
The complete AURORE PHARMACEUTICALS PRIVATE LIMITED file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Hyderabad, India
One Form 483 · 2024 · 5 observations
Latest: Form 483, May 31, 2024 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-05-31 | 483 Form 483 | Hyderabad, India | 5 | $99 |
Investigators on these documents
FEI number 3003937580 · most recent document May 31, 2024
About AURORE PHARMACEUTICALS PRIVATE LIMITED
How many FDA Form 483s has AURORE PHARMACEUTICALS PRIVATE LIMITED received?
FDA Intel has 1 Form 483 on file for AURORE PHARMACEUTICALS PRIVATE LIMITED; the most recent is dated May 31, 2024.
When was AURORE PHARMACEUTICALS PRIVATE LIMITED last inspected by FDA?
The most recent FDA inspection document on file for AURORE PHARMACEUTICALS PRIVATE LIMITED is a Form 483 dated May 31, 2024, for the site in Hyderabad, India.
What did FDA cite at AURORE PHARMACEUTICALS PRIVATE LIMITED?
The regulations cited most in the observations on file for AURORE PHARMACEUTICALS PRIVATE LIMITED are 21 CFR 211.100 (Written procedures; deviations), 1 time; 21 CFR 211.166 (Stability testing), 1 time; 21 CFR 211.192 (Production record review), 1 time.