Healthtronics, Inc.
Form 483 issued May 20, 2015 · Austin, Texas
- Inspection
- May 11 – May 20, 2015
- Investigator
- Iris C. Majzirmes
- Observations
- 2
- Pages
- 3
- FEI number
- 3008262715
In short: On May 20, 2015, FDA issued a Form 483 with 2 observations to Healthtronics, Inc. in Austin, Texas (FEI 3008262715) after an inspection that ran May 11 – May 20, 2015. The investigator was Iris C. Majzirmes. Most observations concern cAPA; the most-cited regulation is 21 CFR 803.50 (if I am a manufacturer, what reporting requirements apply to me?).
At a glance
2 of 2 observations on this 483 concern capa.
Most cited: 21 CFR 803.50(a)(1) (1×) · 820.100(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of…
- 02
Corrective and preventive action activities and/or results…
This inspection in context
Iris C. Majzirmes
1 document · 2015
Cites 803.50(a)(1) (if i am a manufacturer, what reporting requirements apply to me?) more than any other section. Most of their documents are for sites in Texas.
The firmHealthtronics, Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 803.50(a)(1)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Healthtronics, Inc.?
FDA listed 2 observations on this Form 483, mostly about cAPA. The most-cited regulation is 21 CFR 803.50 (if I am a manufacturer, what reporting requirements apply to me?). The opening words of each observation are shown on this page.
Who inspected Healthtronics, Inc.?
Iris C. Majzirmes is named on this Form 483, for the inspection of May 11 – May 20, 2015. Each investigator has a profile showing what they cite most.
When was Healthtronics, Inc. inspected by FDA?
The inspection ran May 11 – May 20, 2015, and the Form 483 is dated May 20, 2015.
How do I get the full Form 483 for Healthtronics, 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.