Bora Pharmaceuticals Injectables Inc.
Form 483 issued August 10, 2023 · Baltimore, Maryland
- Inspection
- Jul 31 – Aug 10, 2023
- Investigators
- Annet R. Rajan· Janet A. Rajan
- Observations
- 4
- Pages
- 6
- FEI number
- 1000512361
In short: On August 10, 2023, FDA issued a Form 483 with 4 observations to Bora Pharmaceuticals Injectables Inc. in Baltimore, Maryland (FEI 1000512361) after an inspection that ran Jul 31 – Aug 10, 2023. The investigators were Annet R. Rajan and Janet A. Rajan. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and quality system account for 3 of 4 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 control systems necessary to prevent contamination…
- 02
The responsibilities and procedures applicable to the quality control unit are not in…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
- 04
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
This inspection in context
Annet R. Rajan
16 documents · 2020–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in New Jersey.
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 4 observations on this Form 483, mostly about production, quality system 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.?
Annet R. Rajan and Janet A. Rajan are named on this Form 483, for the inspection of Jul 31 – Aug 10, 2023. Each investigator has a profile showing what they cite most.
When was Bora Pharmaceuticals Injectables Inc. inspected by FDA?
The inspection ran Jul 31 – Aug 10, 2023, and the Form 483 is dated August 10, 2023.
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.