Ventec Life Systems, Inc

FDA inspection history in Bothell, Washington, 2021

1
Form 483

Every document, by year

  • Form 483

2021: one Form 483.

The story so far

Built from the dates and citations on the documents themselves.

  1. 2021One Form 483, at Bothell, Washington.

Cited most

Across all Ventec Life Systems observations on file

  • 21 CFR 803.17(a)(1)
    What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?
    1
  • 21 CFR 820.100(a)
    Corrective and preventive action
    1

The complete Ventec Life Systems file.

All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.

$99

The documents one by one, while the file is prepared

See the documents

Sites

Documents

1 on file, newest first
DateDocumentPrice
2021-05-12483 Form 483$99

Investigators on these documents

Paul M. Kawamoto (1)

FEI number 3013095415 · most recent document May 12, 2021

About Ventec Life Systems, Inc

How many FDA Form 483s has Ventec Life Systems, Inc received?

FDA Intel has 1 Form 483 on file for Ventec Life Systems, Inc; the most recent is dated May 12, 2021.

When was Ventec Life Systems, Inc last inspected by FDA?

The most recent FDA inspection document on file for Ventec Life Systems, Inc is a Form 483 dated May 12, 2021, for the site in Bothell, Washington.

What did FDA cite at Ventec Life Systems, Inc?

The regulations cited most in the observations on file for Ventec Life Systems, Inc are 21 CFR 803.17(a)(1) (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.