Bora Pharmaceuticals Injectables Inc.
Form 483 issued April 16, 2021 · Baltimore, Maryland
- Inspection
- Apr 12 – Apr 16, 2021
- Investigators
- Kathleen M. Jordan· Robert J. Martin
- Observations
- 4
- Pages
- 4
- FEI number
- 1000512361
In short: On April 16, 2021, FDA issued a Form 483 with 4 observations to Bora Pharmaceuticals Injectables Inc. in Baltimore, Maryland (FEI 1000512361) after an inspection that ran Apr 12 – Apr 16, 2021. The investigators were Kathleen M. Jordan and Robert J. Martin. Most observations concern quality system and materials.
At a glance
Quality system and materials account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review the failure of a batch or any of its…
- 02
Failure to reject any lot of components, drug product containers and closures that did not meet…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 04
Written records of major equipment use are not included…
This inspection in context
Kathleen M. Jordan
6 documents · 2021–2023
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Maryland.
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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Bora Pharmaceuticals Injectables Inc.?
FDA listed 4 observations on this Form 483, mostly about quality system, materials and production. The opening words of each observation are shown on this page.
Who inspected Bora Pharmaceuticals Injectables Inc.?
Kathleen M. Jordan and Robert J. Martin are named on this Form 483, for the inspection of Apr 12 – Apr 16, 2021. Each investigator has a profile showing what they cite most.
When was Bora Pharmaceuticals Injectables Inc. inspected by FDA?
The inspection ran Apr 12 – Apr 16, 2021, and the Form 483 is dated April 16, 2021.
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.