Bora Pharmaceuticals Injectables Inc.
Form 483 issued June 13, 2018 · Baltimore, Maryland
- Inspection
- Jun 4 – Jun 13, 2018
- Investigators
- Debra M. Emerson· Malgorzata G. Norton
- Observations
- 8
- Pages
- 4
- FEI number
- 1000512361
In short: On June 13, 2018, FDA issued a Form 483 with 8 observations to Bora Pharmaceuticals Injectables Inc. in Baltimore, Maryland (FEI 1000512361) after an inspection that ran Jun 4 – Jun 13, 2018. The investigators were Debra M. Emerson and Malgorzata G. Norton. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and facilities & equipment account for 6 of 8 observations.
Most cited: 21 CFR 211.113 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The manufacturing process for…
- 02
Deviations from written production and process control procedures I…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
- 04
Buildings and coolers do not have adequate space for the orderly placement of materials to prevent…
This inspection in context
Debra M. Emerson
27 documents · 2008–2022
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Massachusetts.
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 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Bora Pharmaceuticals Injectables Inc.?
FDA listed 8 observations on this Form 483, mostly about production and facilities & equipment. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Bora Pharmaceuticals Injectables Inc.?
Debra M. Emerson and Malgorzata G. Norton are named on this Form 483, for the inspection of Jun 4 – Jun 13, 2018. Each investigator has a profile showing what they cite most.
When was Bora Pharmaceuticals Injectables Inc. inspected by FDA?
The inspection ran Jun 4 – Jun 13, 2018, and the Form 483 is dated June 13, 2018.
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.