Ortho Biologies LLC
Form 483 issued January 16, 2015 · Manati, Puerto Rico
- Inspection
- Jan 9 – Jan 16, 2015
- Investigator
- Noreen Muniz
- Observations
- 1
- Pages
- 1
- FEI number
- 100110299
In short: On January 16, 2015, FDA issued a Form 483 with 1 observation to Ortho Biologies LLC in Manati, Puerto Rico (FEI 100110299) after an inspection that ran Jan 9 – Jan 16, 2015. The investigator was Noreen Muniz. Most observations concern materials; the most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures).
At a glance
1 of 1 observations on this 483 concern materials.
Most cited: 21 CFR 211.84 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Approved procedure i ' Supplier-Material Qualification Process for Large Molecule, was not followed as established.durinu die…
This inspection in context
Noreen Muniz
24 documents · 2008–2022
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in Puerto Rico.
The firmOrtho Biologies LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.84
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Ortho Biologies LLC?
FDA listed 1 observation on this Form 483, mostly about materials. The most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures). The opening words of each observation are shown on this page.
Who inspected Ortho Biologies LLC?
Noreen Muniz is named on this Form 483, for the inspection of Jan 9 – Jan 16, 2015. Each investigator has a profile showing what they cite most.
When was Ortho Biologies LLC inspected by FDA?
The inspection ran Jan 9 – Jan 16, 2015, and the Form 483 is dated January 16, 2015.
How do I get the full Form 483 for Ortho Biologies LLC?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.