Halo Pharmaceutical Inc
Form 483 issued February 17, 2023 · Whippany, New Jersey
- Inspection
- Feb 7 – Feb 17, 2023
- Investigator
- Robin P. Mathew
- Observations
- 1
- Pages
- 2
- FEI number
- 2211084
In short: On February 17, 2023, FDA issued a Form 483 with 1 observation to Halo Pharmaceutical Inc in Whippany, New Jersey (FEI 2211084) after an inspection that ran Feb 7 – Feb 17, 2023. The investigator was Robin P. Mathew. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
1 of 1 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.68 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
This inspection in context
Robin P. Mathew
11 documents · 2020–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in New Jersey.
The firmHalo Pharmaceutical Inc history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.68
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Halo Pharmaceutical Inc?
FDA listed 1 observation on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected Halo Pharmaceutical Inc?
Robin P. Mathew is named on this Form 483, for the inspection of Feb 7 – Feb 17, 2023. Each investigator has a profile showing what they cite most.
When was Halo Pharmaceutical Inc inspected by FDA?
The inspection ran Feb 7 – Feb 17, 2023, and the Form 483 is dated February 17, 2023.
How do I get the full Form 483 for Halo Pharmaceutical 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.