Bora Pharmaceuticals Injectables Inc.
Form 483 issued May 8, 2013 · Baltimore, Maryland
- Inspection
- May 2 – May 8, 2013
- Investigators
- Michael Vardon· Nicole Trudel· Quyen Tran
- Observations
- 4
- Pages
- 3
- FEI number
- 1000512361
In short: On May 8, 2013, FDA issued a Form 483 with 4 observations to Bora Pharmaceuticals Injectables Inc. in Baltimore, Maryland (FEI 1000512361) after an inspection that ran May 2 – May 8, 2013. The investigators were Michael Vardon, Nicole Trudel and Quyen Tran. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.110 (sampling and testing of in-process materials and drug products).
At a glance
Production and facilities & equipment account for 4 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
The process validation (PV) did not demonstrate the ability to manufacture consecutive, successful…
- 02
Procedures are not in place to assure segregation and the prevention of cross contamination, Current procedures…
- 03
There is insufficient cleaning verification…
- 04
There is no time limit established for the pooling process, which involves the pooling of multiple…
This inspection in context
Michael Vardon
1 document · 2013
Cites 211.110 (sampling and testing of in-process materials and drug products) 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 211.110
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 production and facilities & equipment. 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.?
Michael Vardon, Nicole Trudel and Quyen Tran are named on this Form 483, for the inspection of May 2 – May 8, 2013. Each investigator has a profile showing what they cite most.
When was Bora Pharmaceuticals Injectables Inc. inspected by FDA?
The inspection ran May 2 – May 8, 2013, and the Form 483 is dated May 8, 2013.
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.