Bora Pharmaceuticals Inc.
Form 483 issued August 30, 2022 · Plymouth, Minnesota
- Inspection
- Aug 17 – Aug 30, 2022
- Investigator
- Soyinka S. Eneng
- Observations
- 1
- Pages
- 4
- FEI number
- 3004106442
In short: On August 30, 2022, FDA issued a Form 483 with 1 observation to Bora Pharmaceuticals Inc. in Plymouth, Minnesota (FEI 3004106442) after an inspection that ran Aug 17 – Aug 30, 2022. The investigator was Soyinka S. Eneng. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
1 of 1 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.67 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent malfunctions and…
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 211.67
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 facilities & equipment. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). 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 Aug 17 – Aug 30, 2022. Each investigator has a profile showing what they cite most.
When was Bora Pharmaceuticals Inc. inspected by FDA?
The inspection ran Aug 17 – Aug 30, 2022, and the Form 483 is dated August 30, 2022.
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.