Apneicare LLC
Form 483 issued May 5, 2015 · Worthington, Ohio
- Inspection
- Apr 28 – May 5, 2015
- Investigator
- Rosanna M. Goodrich
- Observations
- 5
- Pages
- 3
- FEI number
- 3007799743
In short: On May 5, 2015, FDA issued a Form 483 with 5 observations to Apneicare LLC in Worthington, Ohio (FEI 3007799743) after an inspection that ran Apr 28 – May 5, 2015. The investigator was Rosanna M. Goodrich. Most observations concern cAPA and management controls.
At a glance
3 of 5 observations on this 483 concern capa.
What FDA observed
Preview: the opening words of each observation- 01
Procedures for corrective and preventive action…
- 02
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit…
- 03
Written MDR procedures have…
- 04
Procedures for quality audits…
This inspection in context
Rosanna M. Goodrich
13 documents · 2015–2025
Cites 820.100(a) (corrective and preventive action) more than any other section. Most of their documents are for sites in Ohio.
The firmApneicare LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Apneicare LLC?
FDA listed 5 observations on this Form 483, mostly about cAPA and management controls. The opening words of each observation are shown on this page.
Who inspected Apneicare LLC?
Rosanna M. Goodrich is named on this Form 483, for the inspection of Apr 28 – May 5, 2015. Each investigator has a profile showing what they cite most.
When was Apneicare LLC inspected by FDA?
The inspection ran Apr 28 – May 5, 2015, and the Form 483 is dated May 5, 2015.
How do I get the full Form 483 for Apneicare 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.