Maxx Orthopedics Inc
Form 483 issued February 27, 2015 · Plymouth Meeting, Pennsylvania
- Inspection
- Feb 18 – Feb 27, 2015
- Investigator
- Raffi B. Papazian
- Observations
- 2
- Pages
- 2
- FEI number
- 3009341131
In short: On February 27, 2015, FDA issued a Form 483 with 2 observations to Maxx Orthopedics Inc in Plymouth Meeting, Pennsylvania (FEI 3009341131) after an inspection that ran Feb 18 – Feb 27, 2015. The investigator was Raffi B. Papazian. Most observations concern production & process controls; the most-cited regulation is 21 CFR 820.70 (production and process controls).
At a glance
2 of 2 observations on this 483 concern production & process controls.
Most cited: 21 CFR 820.70 (1×) · 820.50 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The equipment used in the manufacturing process does…
- 02
There is no agreement with suppliers to notify you of changes in…
This inspection in context
Raffi B. Papazian
1 document · 2015
Cites 820.50 (purchasing controls) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmMaxx Orthopedics Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.70
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Maxx Orthopedics Inc?
FDA listed 2 observations on this Form 483, mostly about production & process controls. The most-cited regulation is 21 CFR 820.70 (production and process controls). The opening words of each observation are shown on this page.
Who inspected Maxx Orthopedics Inc?
Raffi B. Papazian is named on this Form 483, for the inspection of Feb 18 – Feb 27, 2015. Each investigator has a profile showing what they cite most.
When was Maxx Orthopedics Inc inspected by FDA?
The inspection ran Feb 18 – Feb 27, 2015, and the Form 483 is dated February 27, 2015.
How do I get the full Form 483 for Maxx Orthopedics 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.