Overview
- 30 FDA inspections are on record.
- 16 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-03-20.
At a glance
Inspections
30
Form 483s
16
EIRs
7
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 12 Mar 2026 – 20 Mar 2026 | Human Drugs | 483 | View 483 → |
| 17 Jul 2024 – 25 Jul 2024 | Biologics | Clean | |
| 31 Jul 2023 – 10 Aug 2023 | Human Drugs | 483 | View 483 → |
| 7 Feb 2022 – 18 Feb 2022 | Human Drugs | 483 | View 483 → |
| 12 Apr 2021 – 16 Apr 2021 | Human Drugs | 483 | View 483 → |
| 7 May 2019 – 10 May 2019 | Human Drugs | Clean | |
| 4 Jun 2018 – 13 Jun 2018 | Biologics | 483 | On file |
| 23 Jan 2017 – 27 Jan 2017 | Human Drugs | 483 | On file |
| 13 Dec 2016 – 20 Dec 2016 | Human Drugs | 483 | View 483 → |
| 17 Aug 2015 – 28 Aug 2015 | Human Drugs | 483 | View 483 → |
| 18 Aug 2014 – 26 Aug 2014 | Human Drugs | 483 | View 483 → |
| 31 Mar 2014 – 9 Apr 2014 | Human Drugs | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
20 Mar 2026
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Zhong Li, Sudipan Karmakar, Brandy N Lepage, Tekalign Wondimu, Hyung-Yul Lee
20 Mar 2026
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Zhong Li, Sudipan Karmakar, Brandy N Lepage, Tekalign Wondimu, Hyung-Yul Lee
20 Mar 2026
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Zhong Li, Sudipan Karmakar, Brandy N Lepage, Tekalign Wondimu, Hyung-Yul Lee
20 Mar 2026
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Zhong Li, Sudipan Karmakar, Brandy N Lepage, Tekalign Wondimu, Hyung-Yul Lee
20 Mar 2026
21 CFR 211.42(c)(5)
Mfg / Processing Operations Area
Cited by Zhong Li, Sudipan Karmakar, Brandy N Lepage, Tekalign Wondimu, Hyung-Yul Lee
Investigators
FDA investigators tied to this site in the record.
Brooke K Higgins4 insp.
Steven P Donald3 insp.
Ernest Bizjak3 insp.
Robert J Martin2 insp.
Rachel C Harrington2 insp.
Merideth K Rose2 insp.
Zhong Li1 insp.
Sudipan Karmakar1 insp.
Brandy N Lepage1 insp.
Tekalign Wondimu1 insp.
Hyung-Yul Lee1 insp.
Burnell M Henry1 insp.
Priscilla M Pastrana1 insp.
Annet R Rajan1 insp.
Janet A Rajan1 insp.
Sena G Dissmeyer1 insp.
Kathleen M Jordan1 insp.
Derek S Smith1 insp.
Hongna Wang1 insp.
Debra M Emerson1 insp.
Jessica Hankins1 insp.
Ephrem T Hunde1 insp.
Marion Michaelis1 insp.
Toyin B Oladimeji1 insp.
Pratik S Upadhyay1 insp.
Nicholas A Violand1 insp.
Jonathan W Chapman1 insp.
Nicole K Trudel1 insp.
Quyen T Tran1 insp.
Michael J Vardon1 insp.
William A Warnick1 insp.
Prabhu P Raju1 insp.
Nebil A Oumer1 insp.
Douglas A Campbell1 insp.
Carole L Jones1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.84(e) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.182 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(8) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(v) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(vi) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Bora Pharmaceuticals Injectables Inc's 16 Form 483s
Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat