ARC Medical Inc
Form 483 issued November 14, 2019 · Tucker, Georgia
- Inspection
- Nov 13 – Nov 14, 2019
- Investigator
- Miaja Umaedi
- Observations
- 2
- Pages
- 4
- FEI number
- 1000111925
In short: On November 14, 2019, FDA issued a Form 483 with 2 observations to ARC Medical Inc in Tucker, Georgia (FEI 1000111925) after an inspection that ran Nov 13 – Nov 14, 2019. The investigator was Miaja Umaedi. Most observations concern production & process controls and management controls; the most-cited regulation is 21 CFR 820.50 (purchasing controls).
At a glance
Production & process controls and management controls account for 2 of 2 observations.
Most cited: 21 CFR 820.50 (1×) · 820.25(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements…
- 02
Procedures for training and identifying training needs have…
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 firmARC Medical Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.50
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at ARC Medical Inc?
FDA listed 2 observations on this Form 483, mostly about production & process controls and management controls. The most-cited regulation is 21 CFR 820.50 (purchasing controls). The opening words of each observation are shown on this page.
Who inspected ARC Medical Inc?
Miaja Umaedi is named on this Form 483, for the inspection of Nov 13 – Nov 14, 2019. Each investigator has a profile showing what they cite most.
When was ARC Medical Inc inspected by FDA?
The inspection ran Nov 13 – Nov 14, 2019, and the Form 483 is dated November 14, 2019.
How do I get the full Form 483 for ARC 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.