Innovative Therapies, Inc
Form 483 issued August 27, 2015 · Pompano Beach, Florida
- Inspection
- Aug 24 – Aug 27, 2015
- Investigator
- Karen M. Rodriguez
- Observations
- 3
- Pages
- 3
- FEI number
- 3006367520
In short: On August 27, 2015, FDA issued a Form 483 with 3 observations to Innovative Therapies, Inc in Pompano Beach, Florida (FEI 3006367520) after an inspection that ran Aug 24 – Aug 27, 2015. The investigator was Karen M. Rodriguez. Most observations concern cAPA and design controls.
At a glance
CAPA and design controls account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have…
- 02
The design was not validated using initial production units, lots or…
- 03
The evaluation of potential suppliers and…
This inspection in context
Karen M. Rodriguez
8 documents · 2015–2022
Cites 820.198(a) (complaint files) more than any other section. Most of their documents are for sites in Florida.
The firmInnovative Therapies, Inc 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 Innovative Therapies, Inc?
FDA listed 3 observations on this Form 483, mostly about cAPA, design controls and production & process controls. The opening words of each observation are shown on this page.
Who inspected Innovative Therapies, Inc?
Karen M. Rodriguez is named on this Form 483, for the inspection of Aug 24 – Aug 27, 2015. Each investigator has a profile showing what they cite most.
When was Innovative Therapies, Inc inspected by FDA?
The inspection ran Aug 24 – Aug 27, 2015, and the Form 483 is dated August 27, 2015.
How do I get the full Form 483 for Innovative Therapies, 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.