Ortho Biologies LLC
FDA inspection history in Manati, Puerto Rico, 2015
- 1
- Form 483
Every document, by year
- Form 483
2015: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2015One Form 483, at Manati, Puerto Rico.
Cited most
Across all Ortho Biologies observations on file
- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures1
The complete Ortho Biologies file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Manati, Puerto Rico
One Form 483 · 2015 · 1 observation
Latest: Form 483, Jan 16, 2015 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2015-01-16 | 483 Form 483 | Manati, Puerto Rico | 1 | $99 |
Investigators on these documents
FEI number 100110299 · most recent document Jan 16, 2015
About Ortho Biologies LLC
How many FDA Form 483s has Ortho Biologies LLC received?
FDA Intel has 1 Form 483 on file for Ortho Biologies LLC; the most recent is dated Jan 16, 2015.
When was Ortho Biologies LLC last inspected by FDA?
The most recent FDA inspection document on file for Ortho Biologies LLC is a Form 483 dated Jan 16, 2015, for the site in Manati, Puerto Rico.
What did FDA cite at Ortho Biologies LLC?
The regulations cited most in the observations on file for Ortho Biologies LLC are 21 CFR 211.84 (Testing and approval or rejection of components, drug product containers, and closures), 1 time.