Halo Pharmaceutical Inc
Form 483 issued December 20, 2019 · Whippany, New Jersey
- Inspection
- Dec 9 – Dec 20, 2019
- Investigator
- Zhijin Chen
- Observations
- 2
- Pages
- 4
- FEI number
- 2211084
In short: On December 20, 2019, FDA issued a Form 483 with 2 observations to Halo Pharmaceutical Inc in Whippany, New Jersey (FEI 2211084) after an inspection that ran Dec 9 – Dec 20, 2019. The investigator was Zhijin Chen. Most observations concern materials and quality system; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Materials and quality system account for 2 of 2 observations.
Most cited: 21 CFR 211.142 (1×) · 211.22 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures describing the warehousing of drug…
- 02
The responsibilities and procedures applicable to the quality control unit…
This inspection in context
Zhijin Chen
1 document · 2019
Cites 211.142 (warehousing procedures) 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 211.142
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Halo Pharmaceutical Inc?
FDA listed 2 observations on this Form 483, mostly about materials and quality system. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Halo Pharmaceutical Inc?
Zhijin Chen is named on this Form 483, for the inspection of Dec 9 – Dec 20, 2019. Each investigator has a profile showing what they cite most.
When was Halo Pharmaceutical Inc inspected by FDA?
The inspection ran Dec 9 – Dec 20, 2019, and the Form 483 is dated December 20, 2019.
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.