Bora Pharmaceuticals Inc.
Form 483 issued December 19, 2018 · Maple Grove, Minnesota
- Inspection
- Dec 11 – Dec 19, 2018
- Investigators
- Courtney R. Ingalsbe· Ross J. Grigsby· Scott A. Golladay
- Observations
- 1
- Pages
- 3
- FEI number
- 3004106442
In short: On December 19, 2018, FDA issued a Form 483 with 1 observation to Bora Pharmaceuticals Inc. in Maple Grove, Minnesota (FEI 3004106442) after an inspection that ran Dec 11 – Dec 19, 2018. The investigators were Courtney R. Ingalsbe, Ross J. Grigsby and Scott A. Golladay. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
1 of 1 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.160 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
This inspection in context
Courtney R. Ingalsbe
4 documents · 2018–2020
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Minnesota.
The firmBora Pharmaceuticals Inc. history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Bora Pharmaceuticals Inc.?
FDA listed 1 observation on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Bora Pharmaceuticals Inc.?
Courtney R. Ingalsbe, Ross J. Grigsby and Scott A. Golladay are named on this Form 483, for the inspection of Dec 11 – Dec 19, 2018. Each investigator has a profile showing what they cite most.
When was Bora Pharmaceuticals Inc. inspected by FDA?
The inspection ran Dec 11 – Dec 19, 2018, and the Form 483 is dated December 19, 2018.
How do I get the full Form 483 for Bora Pharmaceuticals 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.