Orchid Pharma Limited
FDA inspection history in Alathur, India, 2025
- 1
- Form 483
Every document, by year
- Form 483
2025: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2025One Form 483, at Alathur, India.
Cited most
Across all Orchid Pharma Limited observations on file
- 21 CFR 211.67Equipment cleaning and maintenance2
- 21 CFR 211.68Automatic, mechanical, and electronic equipment2
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.25Personnel qualifications1
- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures1
The complete Orchid Pharma Limited file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Alathur, India
One Form 483 · 2025 · 7 observations
Latest: Form 483, Feb 18, 2025 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-02-18 | 483 Form 483 | Alathur, India | 7 | $99 |
Investigators on these documents
FEI number 3003747558 · most recent document Feb 18, 2025
About Orchid Pharma Limited
How many FDA Form 483s has Orchid Pharma Limited received?
FDA Intel has 1 Form 483 on file for Orchid Pharma Limited; the most recent is dated Feb 18, 2025.
When was Orchid Pharma Limited last inspected by FDA?
The most recent FDA inspection document on file for Orchid Pharma Limited is a Form 483 dated Feb 18, 2025, for the site in Alathur, India.
What did FDA cite at Orchid Pharma Limited?
The regulations cited most in the observations on file for Orchid Pharma Limited are 21 CFR 211.67 (Equipment cleaning and maintenance), 2 times; 21 CFR 211.68 (Automatic, mechanical, and electronic equipment), 2 times; 21 CFR 211.100 (Written procedures; deviations), 1 time.