Sunrise Pharmaceutical, Inc.
Form 483 issued January 18, 2018 · RAHWAY, New Jersey
- Inspection
- Jan 9 – Jan 18, 2018
- Investigator
- Yvesna Blaise
- Observations
- 1
- Pages
- 1
- FEI number
- 3004813394
In short: On January 18, 2018, FDA issued a Form 483 with 1 observation to Sunrise Pharmaceutical, Inc. in RAHWAY, New Jersey (FEI 3004813394) after an inspection that ran Jan 9 – Jan 18, 2018. The investigator was Yvesna Blaise. Most observations concern quality system; the most-cited regulation is 21 CFR 211.25 (personnel qualifications).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.25(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
GMP training is not conducted on a continuing basis to assure that employees remain familiar with…
This inspection in context
Yvesna Blaise
8 documents · 2016–2020
Cites 211.165 (testing and release for distribution) more than any other section. Most of their documents are for sites in New Jersey.
The firmSunrise Pharmaceutical, Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.25(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Sunrise Pharmaceutical, Inc.?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.25 (personnel qualifications). The opening words of each observation are shown on this page.
Who inspected Sunrise Pharmaceutical, Inc.?
Yvesna Blaise is named on this Form 483, for the inspection of Jan 9 – Jan 18, 2018. Each investigator has a profile showing what they cite most.
When was Sunrise Pharmaceutical, Inc. inspected by FDA?
The inspection ran Jan 9 – Jan 18, 2018, and the Form 483 is dated January 18, 2018.
How do I get the full Form 483 for Sunrise 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.