Stimwave Technologies Inc 1310 Park Central Blvd S$
Form 483 issued February 15, 2019 · Pompano Beach, Florida
- Inspection
- Jan 29 – Feb 15, 2019
- Investigators
- David M. Wilkinson· Karen M. Rodriguez
- Observations
- 1
- Pages
- 10
- FEI number
- 3010676138
In short: On February 15, 2019, FDA issued a Form 483 with 1 observation to Stimwave Technologies Inc 1310 Park Central Blvd S$ in Pompano Beach, Florida (FEI 3010676138) after an inspection that ran Jan 29 – Feb 15, 2019. The investigators were David M. Wilkinson and Karen M. Rodriguez. Most observations concern cAPA; the most-cited regulation is 21 CFR 820.198 (complaint files).
At a glance
1 of 1 observations on this 483 concern capa.
Most cited: 21 CFR 820.198(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have…
This inspection in context
David M. Wilkinson
7 documents · 2018–2025
Cites 820.198(a) (complaint files) more than any other section. Most of their documents are for sites in Florida.
The firmStimwave Technologies Inc 1310 Park Central Blvd S$ history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.198(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Stimwave Technologies Inc 1310 Park Central Blvd S$?
FDA listed 1 observation on this Form 483, mostly about cAPA. The most-cited regulation is 21 CFR 820.198 (complaint files). The opening words of each observation are shown on this page.
Who inspected Stimwave Technologies Inc 1310 Park Central Blvd S$?
David M. Wilkinson and Karen M. Rodriguez are named on this Form 483, for the inspection of Jan 29 – Feb 15, 2019. Each investigator has a profile showing what they cite most.
When was Stimwave Technologies Inc 1310 Park Central Blvd S$ inspected by FDA?
The inspection ran Jan 29 – Feb 15, 2019, and the Form 483 is dated February 15, 2019.
How do I get the full Form 483 for Stimwave Technologies Inc 1310 Park Central Blvd S$?
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.