Love Rehab Solutions
Form 483 issued December 17, 2019 · Oxford, Georgia
- Inspection
- Dec 16 – Dec 17, 2019
- Investigator
- Miaja Umaedi
- Observations
- 4
- Pages
- 4
- FEI number
- 3014650130
In short: On December 17, 2019, FDA issued a Form 483 with 4 observations to Love Rehab Solutions in Oxford, Georgia (FEI 3014650130) after an inspection that ran Dec 16 – Dec 17, 2019. The investigator was Miaja Umaedi. Most observations concern records & documents and management controls.
At a glance
Records & documents and management controls account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
Quality system procedures and instructions…
- 02
The design history file…
- 03
A device master record…
- 04
A device history record…
This inspection in context
Miaja Umaedi
4 documents · 2015–2022
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Georgia.
The firmLove Rehab Solutions history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.20(e)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Love Rehab Solutions?
FDA listed 4 observations on this Form 483, mostly about records & documents, management controls and design controls. The opening words of each observation are shown on this page.
Who inspected Love Rehab Solutions?
Miaja Umaedi is named on this Form 483, for the inspection of Dec 16 – Dec 17, 2019. Each investigator has a profile showing what they cite most.
When was Love Rehab Solutions inspected by FDA?
The inspection ran Dec 16 – Dec 17, 2019, and the Form 483 is dated December 17, 2019.
How do I get the full Form 483 for Love Rehab Solutions?
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.