Bora Pharmaceuticals Injectables Inc.
FDA inspection history across 2 sites, 2010 to 2026
- 12
- Form 483s
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2010: one Form 483; 2011: one Form 483; 2012: one Form 483; 2013: one Form 483; 2014: two Form 483s; 2016: one Form 483; 2018: one Form 483; 2021: one Form 483; 2022: one warning letter and one Form 483; 2023: one Form 483; 2026: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2010–18Eight Form 483s, at Baltimore, Maryland.
- 2018The longest 483 on file: 8 observations over 4 pages at Baltimore, Maryland.
- 2021–23Three Form 483s and one warning letter, at Baltimore, Maryland and Gaithersburg, Maryland.
- 2026One Form 483, at Baltimore, Maryland.
Cited most
Across all Bora Pharmaceuticals Injectables observations on file
- 21 CFR 211.113Control of microbiological contamination10
- 21 CFR 211.67Equipment cleaning and maintenance7
- 21 CFR 211.42Design and construction features5
- 21 CFR 211.100Written procedures; deviations3
- 21 CFR 211.192Production record review3
The complete Bora Pharmaceuticals Injectables file.
All 13 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
25% off buying them one by one
Sites
Baltimore, Maryland
12 Form 483s · 2010 to 2026 · 41 observations
Latest: Form 483, Mar 20, 2026 →Gaithersburg, Maryland
One warning letter · 2022
Latest: Warning letter, Aug 10, 2022 →
Documents
13 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2026-03-20 | 483 Form 483 | Baltimore, Maryland | 6 | $99 |
| 2023-08-10 | 483 Form 483 | Baltimore, Maryland | 4 | $99 |
| 2022-08-10 | Warning letter Warning letter | Gaithersburg, Maryland | — | $99 |
| 2022-02-18 | 483 Form 483 | Baltimore, Maryland | 6 | $99 |
| 2021-04-16 | 483 Form 483 | Baltimore, Maryland | 4 | $99 |
| 2018-06-13 | 483 Form 483 | Baltimore, Maryland | 8 | $99 |
| 2016-12-20 | 483 Form 483 | Baltimore, Maryland | 1 | $99 |
| 2014-08-26 | 483 Form 483 | Baltimore, Maryland | 2 | $99 |
| 2014-04-09 | 483 Form 483 | Baltimore, Maryland | 1 | $99 |
| 2013-05-08 | 483 Form 483 | Baltimore, Maryland | 4 | $99 |
| 2012-08-01 | 483 Form 483 | Baltimore, Maryland | 1 | $99 |
| 2011-07-22 | 483 Form 483 | Baltimore, Maryland | 4 | $99 |
| 2010-08-27 | 483 Form 483 | Baltimore, Maryland | — | $99 |
Investigators on these documents
Brooke K. Higgins (2)Robert J. Martin (2)Debra M. Emerson (1)Ernest F. Bizjak (1)Hyung-Yul Lee (1)Janet A. Rajan (1)Jonathan W. Chapman (1)Kathleen M. Jordan (1)Malgorzata G. Norton (1)Michael Vardon (1)Nicholas Violand (1)Nicole Trudel (1)
FEI number 1000512361 · most recent document Mar 20, 2026
About Bora Pharmaceuticals Injectables Inc.
How many FDA Form 483s has Bora Pharmaceuticals Injectables Inc. received?
FDA Intel has 12 Form 483s on file for Bora Pharmaceuticals Injectables Inc.; the most recent is dated Mar 20, 2026.
When was Bora Pharmaceuticals Injectables Inc. last inspected by FDA?
The most recent FDA inspection document on file for Bora Pharmaceuticals Injectables Inc. is a Form 483 dated Mar 20, 2026, for the site in Baltimore, Maryland.
What did FDA cite at Bora Pharmaceuticals Injectables Inc.?
The regulations cited most in the observations on file for Bora Pharmaceuticals Injectables Inc. are 21 CFR 211.113 (Control of microbiological contamination), 10 times; 21 CFR 211.67 (Equipment cleaning and maintenance), 7 times; 21 CFR 211.42 (Design and construction features), 5 times.
Has Bora Pharmaceuticals Injectables Inc. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Bora Pharmaceuticals Injectables Inc.; the most recent is dated Aug 10, 2022.