Ortho Clinicial Diagnostics, Inc
Form 483 issued May 15, 2015 · Rochester, New York
- Inspection
- May 11 – May 15, 2015
- Investigator
- Nicholas C. Mendiola
- Observations
- 1
- Pages
- 2
In short: On May 15, 2015, FDA issued a Form 483 with 1 observation to Ortho Clinicial Diagnostics, Inc in Rochester, New York after an inspection that ran May 11 – May 15, 2015. The investigator was Nicholas C. Mendiola. Most observations concern design controls; the most-cited regulation is 21 CFR 820.30 (design controls).
At a glance
1 of 1 observations on this 483 concern design controls.
Most cited: 21 CFR 820.30 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures for design output have…
This inspection in context
Nicholas C. Mendiola
4 documents · 2015–2018
Cites 803.17 (what are the requirements for developing, maintaining, and implementing written mdr procedures that apply to me?) more than any other section. Most of their documents are for sites in New York.
The firmOrtho Clinicial Diagnostics, Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.30
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Ortho Clinicial Diagnostics, Inc?
FDA listed 1 observation on this Form 483, mostly about design controls. The most-cited regulation is 21 CFR 820.30 (design controls). The opening words of each observation are shown on this page.
Who inspected Ortho Clinicial Diagnostics, Inc?
Nicholas C. Mendiola is named on this Form 483, for the inspection of May 11 – May 15, 2015. Each investigator has a profile showing what they cite most.
When was Ortho Clinicial Diagnostics, Inc inspected by FDA?
The inspection ran May 11 – May 15, 2015, and the Form 483 is dated May 15, 2015.
How do I get the full Form 483 for Ortho Clinicial Diagnostics, Inc?
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.