Bora Pharmaceuticals Injectables Inc.
Form 483 issued July 22, 2011 · Baltimore, Maryland
- Inspection
- Jul 18 – Jul 22, 2011
- Investigators
- Brooke K. Higgins· Ernest F. Bizjak· William A. Warnick
- Observations
- 4
- Pages
- 3
- FEI number
- 1000512361
In short: On July 22, 2011, FDA issued a Form 483 with 4 observations to Bora Pharmaceuticals Injectables Inc. in Baltimore, Maryland (FEI 1000512361) after an inspection that ran Jul 18 – Jul 22, 2011. The investigators were Brooke K. Higgins, Ernest F. Bizjak and William A. Warnick. Most observations concern facilities & equipment and production.
At a glance
Facilities & equipment and production account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in…
- 02
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 04
Employees engaged in the processing of a drug product lack the training required to…
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 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Bora Pharmaceuticals Injectables Inc.?
FDA listed 4 observations on this Form 483, mostly about facilities & equipment, production and quality system. The opening words of each observation are shown on this page.
Who inspected Bora Pharmaceuticals Injectables Inc.?
Brooke K. Higgins, Ernest F. Bizjak and William A. Warnick are named on this Form 483, for the inspection of Jul 18 – Jul 22, 2011. Each investigator has a profile showing what they cite most.
When was Bora Pharmaceuticals Injectables Inc. inspected by FDA?
The inspection ran Jul 18 – Jul 22, 2011, and the Form 483 is dated July 22, 2011.
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.