Bora Pharmaceuticals Injectables Inc.
Form 483 issued December 20, 2016 · Baltimore, Maryland
- Inspection
- Dec 13 – Dec 20, 2016
- Investigator
- Steven P. Donald
- Observations
- 1
- Pages
- 2
- FEI number
- 1000512361
In short: On December 20, 2016, FDA issued a Form 483 with 1 observation to Bora Pharmaceuticals Injectables Inc. in Baltimore, Maryland (FEI 1000512361) after an inspection that ran Dec 13 – Dec 20, 2016. The investigator was Steven P. Donald. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.194 (laboratory records).
At a glance
1 of 1 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.194(a)(8) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Laboratory records do not include the initials or signature of a second person showing that the…
This inspection in context
Steven P. Donald
4 documents · 2016–2018
Cites 211.68 (automatic, mechanical, and electronic equipment) more than any other section. Most of their documents are for sites in China.
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 211.194(a)(8)
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 laboratory controls. The most-cited regulation is 21 CFR 211.194 (laboratory records). The opening words of each observation are shown on this page.
Who inspected Bora Pharmaceuticals Injectables Inc.?
Steven P. Donald is named on this Form 483, for the inspection of Dec 13 – Dec 20, 2016. Each investigator has a profile showing what they cite most.
When was Bora Pharmaceuticals Injectables Inc. inspected by FDA?
The inspection ran Dec 13 – Dec 20, 2016, and the Form 483 is dated December 20, 2016.
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.