Company
United StatesBora Pharmaceuticals Injectables Inc, Baltimore, MD – FDA Inspections
Inspection records and compliance data for Bora Pharmaceuticals Injectables Inc in Baltimore, Maryland. 17 FDA inspections on record (1 OAI), 5 Form 483s, last inspected March 20, 2026.
Company Profile
This profile covers Bora Pharmaceuticals Injectables Inc based in Baltimore, Maryland, United States.
FDA Inspection History
- FDA inspections
- 17
- OAI
- 1
- VAI
- 11
- NAI
- 3
- Unclassified
- 2
- Form 483s
- 5
- Warning letters
- 0
First inspected August 27, 2009. Last inspected March 20, 2026.
Most cited issue areas
- Investigations of discrepancies, failures2 inspections
- Procedures for sterile drug products2 inspections
- Procedures not in writing, fully followed2 inspections
FDA inspections (17)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 20, 2026 | Not classified | Human Drugs · Drug Quality Assurance | 1308344 |
| July 25, 2024 | NAI | Biologics · Blood and Blood Products | 1236852 |
| August 10, 2023 | VAI | Human Drugs · Drug Quality Assurance | 1215798 |
| February 18, 2022 | OAI | Human Drugs · Drug Quality Assurance | 1162959 |
| April 16, 2021 | VAI | Human Drugs · Drug Quality Assurance | 1140286 |
| May 10, 2019 | NAI | Human Drugs · Drug Quality Assurance | 1091850 |
| June 13, 2018 | VAI | Biologics · Blood and Blood Products | 1056814 |
| January 27, 2017 | Not classified | Human Drugs | 1008256 |
| December 20, 2016 | VAI | Human Drugs · Drug Quality Assurance | 997766 |
| August 28, 2015 | VAI | Human Drugs · Drug Quality Assurance | 950170 |
| August 26, 2014 | VAI | Human Drugs · Drug Quality Assurance | 893672 |
| April 9, 2014 | VAI | Human Drugs · Drug Quality Assurance | 873904 |
| August 1, 2012 | VAI | Human Drugs · Drug Quality Assurance | 792496 |
| July 22, 2011 | VAI | Biologics, Human Drugs · Drug Quality Assurance | 735256 |
| August 27, 2010 | VAI | Biologics, Human Drugs, Medical Devices & Rad Health · Drug Quality Assurance | 678345 |
| October 20, 2009 | VAI | Biologics · Blood and Blood Products | 626826 |
| August 27, 2009 | NAI | Human Drugs, Medical Devices & Rad Health · Drug Quality Assurance | 608105 |
FDA documents
Form 483s (12)
EIRs (1)
People (6)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Bora Pharmaceuticals Injectables Inc
FEI Number
1000512361
Address
1111 S Paca St, Baltimore, Maryland 21230, United States
Country
United States
ID: d6e15b21-41fb-4f18-9638-893d3f44fcd1