Wisdom Medical Technologies
Form 483 issued August 19, 2019 · Oswego, Illinois
- Inspection
- Jul 24 – Aug 19, 2019
- Investigator
- Brittani N. Franklin
- Observations
- 1
- Pages
- 10
- FEI number
- 3013532143
In short: On August 19, 2019, FDA issued a Form 483 with 1 observation to Wisdom Medical Technologies in Oswego, Illinois (FEI 3013532143) after an inspection that ran Jul 24 – Aug 19, 2019. The investigator was Brittani N. Franklin. The most-cited regulation is 21 CFR 1010.2 (certification).
What FDA observed
Preview: the opening words of each observation- 01
Failure to furnish to the dealer and distributor, at the time of delivery of a product…
This inspection in context
Brittani N. Franklin
5 documents · 2016–2019
Cites 803.17 (what are the requirements for developing, maintaining, and implementing written mdr procedures that apply to me?) more than any other section. Most of their documents are for sites in Illinois.
The firmWisdom Medical Technologies history
The site's inspection history, in date order.
Similar 483sOther sites cited under 1010.2(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Wisdom Medical Technologies?
FDA listed 1 observation on this Form 483. The most-cited regulation is 21 CFR 1010.2 (certification). The opening words of each observation are shown on this page.
Who inspected Wisdom Medical Technologies?
Brittani N. Franklin is named on this Form 483, for the inspection of Jul 24 – Aug 19, 2019. Each investigator has a profile showing what they cite most.
When was Wisdom Medical Technologies inspected by FDA?
The inspection ran Jul 24 – Aug 19, 2019, and the Form 483 is dated August 19, 2019.
How do I get the full Form 483 for Wisdom Medical Technologies?
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.