FDA Intel

Augustine Biomedical & Design, LLC

FDA inspection history in Bloomington, Minnesota, 2017 to 2024

1
Warning letter
1
Form 483

Every document, by year

  • Warning letter
  • Form 483

2017: one Form 483; 2024: one warning letter.

The story so far

Built from the dates and citations on the documents themselves.

  1. 2017One Form 483, at Bloomington, Minnesota.
  2. 2024One warning letter, at Bloomington, Minnesota.

Cited most

Across all Augustine Biomedical & Design observations on file

The complete Augustine Biomedical & Design file.

All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.

$198

The price of the documents, added to your cart together

Sites

Documents

2 on file, newest first
DateDocumentPrice
2024-03-21Warning letter Warning letter$99
2017-01-04483 Form 483$99

Investigators on these documents

Marissa S. Steinhagen (1)

FEI number 3005857264 · most recent document Mar 21, 2024

About Augustine Biomedical & Design, LLC

How many FDA Form 483s has Augustine Biomedical & Design, LLC received?

FDA Intel has 1 Form 483 on file for Augustine Biomedical & Design, LLC; the most recent is dated Jan 4, 2017.

When was Augustine Biomedical & Design, LLC last inspected by FDA?

The most recent FDA inspection document on file for Augustine Biomedical & Design, LLC is a Form 483 dated Jan 4, 2017, for the site in Bloomington, Minnesota.

What did FDA cite at Augustine Biomedical & Design, LLC?

The regulations cited most in the observations on file for Augustine Biomedical & Design, LLC are 21 CFR 820.198(a) (Complaint files), 1 time.

Has Augustine Biomedical & Design, LLC received an FDA warning letter?

Yes. FDA Intel has 1 FDA warning letter on file for Augustine Biomedical & Design, LLC; the most recent is dated Mar 21, 2024.

Augustine Biomedical & Design, LLC FDA Inspection History & 483s · FDA Intel