Bora Pharmaceuticals Inc.
FDA inspection history across 2 sites, 2018 to 2024
- 3
- Form 483s
Every document, by year
- Form 483
2018: one Form 483; 2022: one Form 483; 2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2018One Form 483, at Maple Grove, Minnesota.
- 2022–24Two Form 483s, at Plymouth, Minnesota.
- 2024The longest 483 on file: 3 observations over 4 pages at Plymouth, Minnesota.
Cited most
Across all Bora Pharmaceuticals observations on file
- 21 CFR 211.67Equipment cleaning and maintenance2
- 21 CFR 211.160General requirements1
- 21 CFR 211.188Batch production and control records1
- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures1
The complete Bora Pharmaceuticals file.
All 3 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Plymouth, Minnesota
Two Form 483s · 2022 to 2024 · 4 observations
Latest: Form 483, Jul 11, 2024 →Maple Grove, Minnesota
One Form 483 · 2018 · 1 observation
Latest: Form 483, Dec 19, 2018 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-07-11 | 483 Form 483 | Plymouth, Minnesota | 3 | $99 |
| 2022-08-30 | 483 Form 483 | Plymouth, Minnesota | 1 | $99 |
| 2018-12-19 | 483 Form 483 | Maple Grove, Minnesota | 1 | $99 |
Investigators on these documents
Soyinka S. Eneng (2)Courtney R. Ingalsbe (1)Ross J. Grigsby (1)Scott A. Golladay (1)
FEI number 3004106442 · most recent document Jul 11, 2024
About Bora Pharmaceuticals Inc.
How many FDA Form 483s has Bora Pharmaceuticals Inc. received?
FDA Intel has 3 Form 483s on file for Bora Pharmaceuticals Inc.; the most recent is dated Jul 11, 2024.
When was Bora Pharmaceuticals Inc. last inspected by FDA?
The most recent FDA inspection document on file for Bora Pharmaceuticals Inc. is a Form 483 dated Jul 11, 2024, for the site in Plymouth, Minnesota.
What did FDA cite at Bora Pharmaceuticals Inc.?
The regulations cited most in the observations on file for Bora Pharmaceuticals Inc. are 21 CFR 211.67 (Equipment cleaning and maintenance), 2 times; 21 CFR 211.160 (General requirements), 1 time; 21 CFR 211.188 (Batch production and control records), 1 time.