Bora Pharmaceuticals Injectables Inc.
Form 483 issued February 18, 2022 · Baltimore, Maryland
- Inspection
- Feb 7 – Feb 18, 2022
- Investigators
- Robert J. Martin· Sena G. Dissmeyer
- Observations
- 6
- Pages
- 7
- FEI number
- 1000512361
In short: On February 18, 2022, FDA issued a Form 483 with 6 observations to Bora Pharmaceuticals Injectables Inc. in Baltimore, Maryland (FEI 1000512361) after an inspection that ran Feb 7 – Feb 18, 2022. The investigators were Robert J. Martin and Sena G. Dissmeyer. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and quality system account for 4 of 6 observations.
Most cited: 21 CFR 211.42 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Aseptic processing areas are deficient regarding systems for maintaining any equipment used to…
- 02
EMPLOYEE{S) SIGNATURE The responsibilities and procedures applicable to the quality control unit…
- 03
Written procedures for cleaning and maintenance fail to include maintenance and cleaning schedules, description in sufficient…
- 04
Procedures designed to prevent microbiological contamination of drug products purporting to be…
This inspection in context
Robert J. Martin
29 documents · 2014–2023
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 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Bora Pharmaceuticals Injectables Inc.?
FDA listed 6 observations on this Form 483, mostly about facilities & equipment, quality system and production. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Bora Pharmaceuticals Injectables Inc.?
Robert J. Martin and Sena G. Dissmeyer are named on this Form 483, for the inspection of Feb 7 – Feb 18, 2022. Each investigator has a profile showing what they cite most.
When was Bora Pharmaceuticals Injectables Inc. inspected by FDA?
The inspection ran Feb 7 – Feb 18, 2022, and the Form 483 is dated February 18, 2022.
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.