INNOVA MEDICAL GROUP, INC
Form 483 issued April 9, 2021 · Pasadena, California
- Inspection
- Mar 15 – Apr 9, 2021
- Investigators
- Dustin P. Tran· Janet Pulver· Marlo-Ian M. Alintanahin
- Observations
- 11
- Pages
- 9
- FEI number
- 3018074194
In short: On April 9, 2021, FDA issued a Form 483 with 11 observations to INNOVA MEDICAL GROUP, INC in Pasadena, California (FEI 3018074194) after an inspection that ran Mar 15 – Apr 9, 2021. The investigators were Dustin P. Tran, Janet Pulver, Marlo-Ian M. Alintanahin and Sunitha K. Rajaram. Most observations concern cAPA and management controls; the most-cited regulation is 21 CFR 820.20 (management responsibility).
At a glance
CAPA and management controls account for 8 of 11 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures for control and distribution of finished devices…
- 02
Procedures for acceptance activities…
- 03
Procedures have not been established to control product that does not conform to specified…
- 04
Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements…
This inspection in context
Dustin P. Tran
3 documents · 2016–2021
Cites 211.42(c)(10)(iii) (design and construction features) more than any other section. Most of their documents are for sites in California.
The firmINNOVA MEDICAL GROUP, INC history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.160(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at INNOVA MEDICAL GROUP, INC?
FDA listed 11 observations on this Form 483, mostly about cAPA, management controls and production & process controls. The most-cited regulation is 21 CFR 820.20 (management responsibility). The opening words of each observation are shown on this page.
Who inspected INNOVA MEDICAL GROUP, INC?
Dustin P. Tran, Janet Pulver, Marlo-Ian M. Alintanahin and Sunitha K. Rajaram are named on this Form 483, for the inspection of Mar 15 – Apr 9, 2021. Each investigator has a profile showing what they cite most.
When was INNOVA MEDICAL GROUP, INC inspected by FDA?
The inspection ran Mar 15 – Apr 9, 2021, and the Form 483 is dated April 9, 2021.
How do I get the full Form 483 for INNOVA MEDICAL GROUP, 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.