Bora Pharmaceuticals Injectables Inc.
Form 483 issued April 9, 2014 · Baltimore, Maryland
- Inspection
- Mar 31 – Apr 9, 2014
- Investigators
- Brooke K. Higgins· Jonathan W. Chapman
- Observations
- 1
- Pages
- 1
- FEI number
- 1000512361
In short: On April 9, 2014, FDA issued a Form 483 with 1 observation to Bora Pharmaceuticals Injectables Inc. in Baltimore, Maryland (FEI 1000512361) after an inspection that ran Mar 31 – Apr 9, 2014. The investigators were Brooke K. Higgins and Jonathan W. Chapman. Most observations concern production; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
1 of 1 observations on this 483 concern production.
Most cited: 21 CFR 211.100(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
There are no written procedures for production and process controls designed to assure that the drug…
This inspection in context
Brooke K. Higgins
5 documents · 2011–2014
Cites 211.42(c)(10) (design and construction features) 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 211.100(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 1 observation on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected Bora Pharmaceuticals Injectables Inc.?
Brooke K. Higgins and Jonathan W. Chapman are named on this Form 483, for the inspection of Mar 31 – Apr 9, 2014. Each investigator has a profile showing what they cite most.
When was Bora Pharmaceuticals Injectables Inc. inspected by FDA?
The inspection ran Mar 31 – Apr 9, 2014, and the Form 483 is dated April 9, 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.