Adapta Medical, Inc
Form 483 issued December 2, 2015 · Colorado Springs, Colorado
- Inspection
- Dec 2, 2015
- Investigator
- Felix J. Marrero
- Observations
- 4
- Pages
- 3
- FEI number
- 3008772421
In short: On December 2, 2015, FDA issued a Form 483 with 4 observations to Adapta Medical, Inc in Colorado Springs, Colorado (FEI 3008772421) after an inspection that ran Dec 2, 2015. The investigator was Felix J. Marrero. Most observations concern production & process controls and records & documents.
At a glance
3 of 4 observations on this 483 concern production & process controls.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
A process whose results cannot be fully verified by subsequent inspection and test has not been…
- 02
Requirements have not been adequately established to…
- 03
There is no agreement with suppliers to notify you of changes in…
- 04
Procedures for device history records…
This inspection in context
Felix J. Marrero
7 documents · 2011–2025
Cites 803 more than any other section. Most of their documents are for sites in Colorado.
The firmAdapta Medical, Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.75
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Adapta Medical, Inc?
FDA listed 4 observations on this Form 483, mostly about production & process controls and records & documents. The opening words of each observation are shown on this page.
Who inspected Adapta Medical, Inc?
Felix J. Marrero is named on this Form 483, for the inspection of Dec 2, 2015. Each investigator has a profile showing what they cite most.
When was Adapta Medical, Inc inspected by FDA?
The inspection ran Dec 2, 2015, and the Form 483 is dated December 2, 2015.
How do I get the full Form 483 for Adapta Medical, 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.