International Medical Industries, Inc
Amended 483 issued April 3, 2018 · Pompano Beach, Florida
- Inspection
- Mar 14 – Apr 3, 2018
- Investigators
- David M. Wilkinson· Stanley B. Eugene
- Observations
- 1
- Pages
- 9
- FEI number
- 1217831
In short: On April 3, 2018, FDA issued a Amended 483 with 1 observation to International Medical Industries, Inc in Pompano Beach, Florida (FEI 1217831) after an inspection that ran Mar 14 – Apr 3, 2018. The investigators were David M. Wilkinson and Stanley B. Eugene. Most observations concern cAPA; the most-cited regulation is 21 CFR 820.198 (complaint files).
At a glance
1 of 1 observations on this amended 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…
The full amended 483
Plus the full detail behind each one, exactly as FDA wrote it.
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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 firmInternational Medical Industries, Inc history
The site's inspection history, in date order.
Similar documentsOther sites cited under 820.198(a)
See how FDA wrote the same problem up elsewhere.
Questions about this amended 483
What did FDA find at International Medical Industries, Inc?
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 International Medical Industries, Inc?
David M. Wilkinson and Stanley B. Eugene are named on this Amended 483, for the inspection of Mar 14 – Apr 3, 2018. Each investigator has a profile showing what they cite most.
When was International Medical Industries, Inc inspected by FDA?
The inspection ran Mar 14 – Apr 3, 2018, and the Amended 483 is dated April 3, 2018.
How do I get the full Amended 483 for International Medical Industries, 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.