Beacon Promotions, Inc.
Form 483 issued January 12, 2018 · Eagan, Minnesota
- Inspection
- Jan 10 – Jan 12, 2018
- Investigators
- James K. Ireland· Tenzin Jangchup
- Observations
- 2
- Pages
- 2
- FEI number
- 3004305946
In short: On January 12, 2018, FDA issued a Form 483 with 2 observations to Beacon Promotions, Inc. in Eagan, Minnesota (FEI 3004305946) after an inspection that ran Jan 10 – Jan 12, 2018. The investigators were James K. Ireland and Tenzin Jangchup. Most observations concern quality system and packaging & labeling; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Quality system and packaging & labeling account for 2 of 2 observations.
Most cited: 21 CFR 211.22(d) (1×) · 211.125(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit are not in…
- 02
Strict control is not exercised over labeling issued for use in…
This inspection in context
James K. Ireland
10 documents · 2016–2019
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Minnesota.
The firmBeacon Promotions, Inc. 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 Beacon Promotions, Inc.?
FDA listed 2 observations on this Form 483, mostly about quality system and packaging & labeling. 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 Beacon Promotions, Inc.?
James K. Ireland and Tenzin Jangchup are named on this Form 483, for the inspection of Jan 10 – Jan 12, 2018. Each investigator has a profile showing what they cite most.
When was Beacon Promotions, Inc. inspected by FDA?
The inspection ran Jan 10 – Jan 12, 2018, and the Form 483 is dated January 12, 2018.
How do I get the full Form 483 for Beacon Promotions, 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.