Allegiant Health
Form 483 issued June 2, 2015 · Deer Park, New York
- Inspection
- May 12 – Jun 2, 2015
- Investigators
- Charisse K. Green· Dilijeta Bajrami
- Observations
- 9
- Pages
- 5
- FEI number
- 3001195380
In short: On June 2, 2015, FDA issued a Form 483 with 9 observations to Allegiant Health in Deer Park, New York (FEI 3001195380) after an inspection that ran May 12 – Jun 2, 2015. The investigators were Charisse K. Green and Dilijeta Bajrami. Most observations concern quality system and materials; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Observations span 4 systems, led by quality system.
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit…
- 02
The quality control unit lacks responsibility to reject all procedures or specifications impacting on the…
- 03
Written records of investigation of a drug complaint do not include the…
- 04
Drug products are not stored under appropriate conditions of temperature and humidity so that their identity…
This inspection in context
Charisse K. Green
5 documents · 2005–2015
Cites 123.6 (hazard analysis and hazard analysis critical control point (haccp) plan) more than any other section. Most of their documents are for sites in New York.
The firmAllegiant Health history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.22(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Allegiant Health?
FDA listed 9 observations on this Form 483, mostly about quality system, materials and facilities & equipment. 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 Allegiant Health?
Charisse K. Green and Dilijeta Bajrami are named on this Form 483, for the inspection of May 12 – Jun 2, 2015. Each investigator has a profile showing what they cite most.
When was Allegiant Health inspected by FDA?
The inspection ran May 12 – Jun 2, 2015, and the Form 483 is dated June 2, 2015.
How do I get the full Form 483 for Allegiant Health?
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.