Bora Pharmaceuticals Inc.
Form 483 issued July 11, 2024 · Plymouth, Minnesota
- Inspection
- Jan 2 – Jul 11, 2024
- Investigator
- Soyinka S. Eneng
- Observations
- 3
- Pages
- 4
- FEI number
- 3004106442
In short: On July 11, 2024, FDA issued a Form 483 with 3 observations to Bora Pharmaceuticals Inc. in Plymouth, Minnesota (FEI 3004106442) after an inspection that ran Jan 2 – Jul 11, 2024. The investigator was Soyinka S. Eneng. Most observations concern materials and facilities & equipment.
At a glance
Materials and facilities & equipment account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Each component is not tested for conformity with all written specifications for…
- 02
Written procedures are not followed for the cleaning and maintenance of equipment, including utensils, used in…
- 03
The batch record do not record the distinctive identification number to identify major equipment to show…
This inspection in context
Soyinka S. Eneng
4 documents · 2022–2025
Cites 211.67 (equipment cleaning and maintenance) 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 211.84
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Bora Pharmaceuticals Inc.?
FDA listed 3 observations on this Form 483, mostly about materials, facilities & equipment and production. The opening words of each observation are shown on this page.
Who inspected Bora Pharmaceuticals Inc.?
Soyinka S. Eneng is named on this Form 483, for the inspection of Jan 2 – Jul 11, 2024. Each investigator has a profile showing what they cite most.
When was Bora Pharmaceuticals Inc. inspected by FDA?
The inspection ran Jan 2 – Jul 11, 2024, and the Form 483 is dated July 11, 2024.
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.