Bora Pharmaceuticals Injectables Inc.
Form 483 issued August 26, 2014 · Baltimore, Maryland
- Inspection
- Aug 18 – Aug 26, 2014
- Investigator
- Nicholas Violand
- Observations
- 2
- Pages
- 2
- FEI number
- 1000512361
In short: On August 26, 2014, FDA issued a Form 483 with 2 observations to Bora Pharmaceuticals Injectables Inc. in Baltimore, Maryland (FEI 1000512361) after an inspection that ran Aug 18 – Aug 26, 2014. The investigator was Nicholas Violand. Most observations concern production and materials; the most-cited regulation is 21 CFR 211.110 (sampling and testing of in-process materials and drug products).
At a glance
Production and materials account for 2 of 2 observations.
Most cited: 21 CFR 211.110(a) (1×) · 211.84(d)(2) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Control procedures are not established which monitor the output and validate the performance of those manufacturing…
- 02
Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity…
This inspection in context
Nicholas Violand
17 documents · 2013–2022
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in New Jersey.
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 211.110(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Bora Pharmaceuticals Injectables Inc.?
FDA listed 2 observations on this Form 483, mostly about production and materials. The most-cited regulation is 21 CFR 211.110 (sampling and testing of in-process materials and drug products). The opening words of each observation are shown on this page.
Who inspected Bora Pharmaceuticals Injectables Inc.?
Nicholas Violand is named on this Form 483, for the inspection of Aug 18 – Aug 26, 2014. Each investigator has a profile showing what they cite most.
When was Bora Pharmaceuticals Injectables Inc. inspected by FDA?
The inspection ran Aug 18 – Aug 26, 2014, and the Form 483 is dated August 26, 2014.
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.