Augustine Biomedical & Design, LLC
Form 483 issued January 4, 2017 · Bloomington, Minnesota
- Inspection
- Dec 13, 2016 – Jan 4, 2017
- Investigator
- Marissa S. Steinhagen
- Observations
- 1
- Pages
- 3
- FEI number
- 3005857264
In short: On January 4, 2017, FDA issued a Form 483 with 1 observation to Augustine Biomedical & Design, LLC in Bloomington, Minnesota (FEI 3005857264) after an inspection that ran Dec 13, 2016 – Jan 4, 2017. The investigator was Marissa S. Steinhagen. Most observations concern cAPA; the most-cited regulation is 21 CFR 820.198 (complaint files).
At a glance
1 of 1 observations on this 483 concern capa.
Most cited: 21 CFR 820.198(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have…
This inspection in context
Marissa S. Steinhagen
3 documents · 2016–2019
Cites 820.70(a) (production and process controls) more than any other section. Most of their documents are for sites in Minnesota.
The firmAugustine Biomedical & Design, LLC history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.198(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Augustine Biomedical & Design, LLC?
FDA listed 1 observation on this Form 483, mostly about cAPA. The most-cited regulation is 21 CFR 820.198 (complaint files). The opening words of each observation are shown on this page.
Who inspected Augustine Biomedical & Design, LLC?
Marissa S. Steinhagen is named on this Form 483, for the inspection of Dec 13, 2016 – Jan 4, 2017. Each investigator has a profile showing what they cite most.
When was Augustine Biomedical & Design, LLC inspected by FDA?
The inspection ran Dec 13, 2016 – Jan 4, 2017, and the Form 483 is dated January 4, 2017.
How do I get the full Form 483 for Augustine Biomedical & Design, LLC?
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.