Innovative Surgical Designs, Inc
Form 483 issued August 27, 2015 · Bloomington, Indiana
- Inspection
- Aug 24 – Aug 27, 2015
- Investigator
- Cynthia Li
- Observations
- 6
- Pages
- 3
- FEI number
- 3010586931
In short: On August 27, 2015, FDA issued a Form 483 with 6 observations to Innovative Surgical Designs, Inc in Bloomington, Indiana (FEI 3010586931) after an inspection that ran Aug 24 – Aug 27, 2015. The investigator was Cynthia Li. Most observations concern cAPA and production & process controls; the most-cited regulation is 21 CFR 820.198 (complaint files).
At a glance
4 of 6 observations on this 483 concern capa.
What FDA observed
Preview: the opening words of each observation- 01
Procedures for finished device acceptance have…
- 02
Procedures to ensure sampling methods are adequate for their intended use have…
- 03
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have…
- 04
Procedures for corrective and preventive action have…
This inspection in context
Cynthia Li
1 document · 2015
Cites 820.198(a) (complaint files) more than any other section. Most of their documents are for sites in Indiana.
The firmInnovative Surgical Designs, Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.80(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Innovative Surgical Designs, Inc?
FDA listed 6 observations on this Form 483, mostly about cAPA and production & process controls. The most-cited regulation is 21 CFR 820.198 (complaint files). The opening words of each observation are shown on this page.
Who inspected Innovative Surgical Designs, Inc?
Cynthia Li 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 Surgical Designs, 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 Surgical Designs, 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.