Ferring Microbiome Inc.
Form 483 issued July 9, 2018 · Saint Paul, Minnesota
- Inspection
- Jun 25 – Jul 9, 2018
- Investigator
- Nicole C. Victoria
- Observations
- 1
- Pages
- 7
- FEI number
- 3012047188
In short: On July 9, 2018, FDA issued a Form 483 with 1 observation to Ferring Microbiome Inc. in Saint Paul, Minnesota (FEI 3012047188) after an inspection that ran Jun 25 – Jul 9, 2018. The investigator was Nicole C. Victoria. Most observations concern clinical (BIMO); the most-cited regulation is 21 CFR 312.50 (general responsibilities of sponsors).
At a glance
1 of 1 observations on this 483 concern clinical (bimo).
Most cited: 21 CFR 312.50 (1×)
What FDA observed
Preview: the opening words of each observation- 01
Failure to ensure proper monitoring of the study and ensure the study is conducted in accordance…
This inspection in context
Nicole C. Victoria
1 document · 2018
Cites 312.50 (general responsibilities of sponsors) more than any other section. Most of their documents are for sites in Minnesota.
The firmFerring Microbiome Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 312.50
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Ferring Microbiome Inc.?
FDA listed 1 observation on this Form 483, mostly about clinical (BIMO). The most-cited regulation is 21 CFR 312.50 (general responsibilities of sponsors). The opening words of each observation are shown on this page.
Who inspected Ferring Microbiome Inc.?
Nicole C. Victoria is named on this Form 483, for the inspection of Jun 25 – Jul 9, 2018. Each investigator has a profile showing what they cite most.
When was Ferring Microbiome Inc. inspected by FDA?
The inspection ran Jun 25 – Jul 9, 2018, and the Form 483 is dated July 9, 2018.
How do I get the full Form 483 for Ferring Microbiome Inc.?
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.