Halo Pharmaceutical Inc
Form 483 issued March 20, 2017 · Whippany, New Jersey
- Inspection
- Mar 3 – Mar 20, 2017
- Investigators
- Helen Verdel· Jogy George
- Observations
- 6
- Pages
- 6
- FEI number
- 2211084
In short: On March 20, 2017, FDA issued a Form 483 with 6 observations to Halo Pharmaceutical Inc in Whippany, New Jersey (FEI 2211084) after an inspection that ran Mar 3 – Mar 20, 2017. The investigators were Helen Verdel and Jogy George. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Production and facilities & equipment account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There are no written procedures for production and process controls designed to assure that the drug…
- 02
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 03
Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in…
- 04
Buildings used in the manufacturing and processing of a drug product are not maintained in a…
This inspection in context
Helen Verdel
13 documents · 2015–2023
Cites 211.67 (equipment cleaning and maintenance) 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 211.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Halo Pharmaceutical Inc?
FDA listed 6 observations on this Form 483, mostly about production, facilities & equipment and quality system. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Halo Pharmaceutical Inc?
Helen Verdel and Jogy George are named on this Form 483, for the inspection of Mar 3 – Mar 20, 2017. Each investigator has a profile showing what they cite most.
When was Halo Pharmaceutical Inc inspected by FDA?
The inspection ran Mar 3 – Mar 20, 2017, and the Form 483 is dated March 20, 2017.
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.