Bora Pharmaceuticals Injectables Inc.
Form 483 issued March 20, 2026 · Baltimore, Maryland
- Inspection
- Mar 12 – Mar 20, 2026
- Investigators
- Brandy N. Lepage· Hyung-Yul Lee· Sudipan Karmaker
- Observations
- 6
- Pages
- 17
- FEI number
- 1000512361
In short: On March 20, 2026, FDA issued a Form 483 with 6 observations to Bora Pharmaceuticals Injectables Inc. in Baltimore, Maryland (FEI 1000512361) after an inspection that ran Mar 12 – Mar 20, 2026. The investigators were Brandy N. Lepage, Hyung-Yul Lee, Sudipan Karmaker, Tekalign Wondimu and Zhong Li. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Quality system and facilities & equipment account for 4 of 6 observations.
Most cited: 21 CFR 211.67 (2×) · 211.113 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 02
Written procedures are not followed for the cleaning and maintenance of equipment, including utensils, used in…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
- 04
Separate or defined areas to prevent contamination or mix-ups are deficient regarding the…
This inspection in context
Brandy N. Lepage
31 documents · 2021–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmBora Pharmaceuticals Injectables Inc. history
All 13 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 Injectables Inc.?
FDA listed 6 observations on this Form 483, mostly about quality system, facilities & equipment and production. 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 Injectables Inc.?
Brandy N. Lepage, Hyung-Yul Lee, Sudipan Karmaker, Tekalign Wondimu and Zhong Li are named on this Form 483, for the inspection of Mar 12 – Mar 20, 2026. Each investigator has a profile showing what they cite most.
When was Bora Pharmaceuticals Injectables Inc. inspected by FDA?
The inspection ran Mar 12 – Mar 20, 2026, and the Form 483 is dated March 20, 2026.
How do I get the full Form 483 for Bora Pharmaceuticals Injectables 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.