INNOVA MEDICAL GROUP, INC
FDA inspection history in Pasadena, California, 2021 to 2022
- 1
- Close-out
- 1
- Warning letter
- 1
- Form 483
Every document, by year
- Close-out
- Warning letter
- Form 483
2021: one warning letter and one Form 483; 2022: one close-out letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2021–22One warning letter, one Form 483 and one close-out letter, at Pasadena, California.
Cited most
Across all INNOVA MEDICAL GROUP observations on file
- 21 CFR 820.20(a)Management responsibility2
- 21 CFR 803.17What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?1
- 21 CFR 820.100(a)Corrective and preventive action1
- 21 CFR 820.160(a)Distribution1
- 21 CFR 820.198(a)Complaint files1
The complete INNOVA MEDICAL GROUP file.
All 3 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Pasadena, California
One close-out letter, one warning letter and one Form 483 · 2021 to 2022 · 11 observations
Latest: Close-out, Oct 21, 2022 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-10-21 | Close-out Close-out letter | Pasadena, California | — | $99 |
| 2021-06-10 | Warning letter Warning letter | Pasadena, California | — | $99 |
| 2021-04-09 | 483 Form 483 | Pasadena, California | 11 | $99 |
Investigators on these documents
Dustin P. Tran (1)Janet Pulver (1)Marlo-Ian M. Alintanahin (1)Sunitha K. Rajaram (1)
FEI number 3018074194 · most recent document Oct 21, 2022
About INNOVA MEDICAL GROUP, INC
How many FDA Form 483s has INNOVA MEDICAL GROUP, INC received?
FDA Intel has 1 Form 483 on file for INNOVA MEDICAL GROUP, INC; the most recent is dated Apr 9, 2021.
When was INNOVA MEDICAL GROUP, INC last inspected by FDA?
The most recent FDA inspection document on file for INNOVA MEDICAL GROUP, INC is a Form 483 dated Apr 9, 2021, for the site in Pasadena, California.
What did FDA cite at INNOVA MEDICAL GROUP, INC?
The regulations cited most in the observations on file for INNOVA MEDICAL GROUP, INC are 21 CFR 820.20(a) (Management responsibility), 2 times; 21 CFR 803.17 (What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?), 1 time; 21 CFR 820.100(a) (Corrective and preventive action), 1 time.
Has INNOVA MEDICAL GROUP, INC received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for INNOVA MEDICAL GROUP, INC; the most recent is dated Jun 10, 2021.