Innovative Surgical Designs, Inc
FDA inspection history in Bloomington, Indiana, 2015
- 1
- Form 483
Every document, by year
- Form 483
2015: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2015One Form 483, at Bloomington, Indiana.
Cited most
Across all Innovative Surgical Designs observations on file
- 21 CFR 820.198(a)Complaint files2
- 21 CFR 820.100(a)Corrective and preventive action1
- 21 CFR 820.250(b)Statistical techniques1
- 21 CFR 820.80(d)Receiving, in-process, and finished device acceptance1
- 21 CFR 820.90(b)(1)Nonconforming product1
The complete Innovative Surgical Designs file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Bloomington, Indiana
One Form 483 · 2015 · 6 observations
Latest: Form 483, Aug 27, 2015 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2015-08-27 | 483 Form 483 | Bloomington, Indiana | 6 | $99 |
Investigators on these documents
FEI number 3010586931 · most recent document Aug 27, 2015
About Innovative Surgical Designs, Inc
How many FDA Form 483s has Innovative Surgical Designs, Inc received?
FDA Intel has 1 Form 483 on file for Innovative Surgical Designs, Inc; the most recent is dated Aug 27, 2015.
When was Innovative Surgical Designs, Inc last inspected by FDA?
The most recent FDA inspection document on file for Innovative Surgical Designs, Inc is a Form 483 dated Aug 27, 2015, for the site in Bloomington, Indiana.
What did FDA cite at Innovative Surgical Designs, Inc?
The regulations cited most in the observations on file for Innovative Surgical Designs, Inc are 21 CFR 820.198(a) (Complaint files), 2 times; 21 CFR 820.100(a) (Corrective and preventive action), 1 time; 21 CFR 820.250(b) (Statistical techniques), 1 time.