American National Red Cross
Form 483 issued August 30, 2013 · Loveland, Colorado
- Inspection
- Aug 5 – Aug 30, 2013
- Investigators
- Andrea S. Heise· Andrew J. Gonzales· Kimberley A. Hoefeo
- Observations
- 5
- Pages
- 13
- FEI number
- 1000148123
In short: On August 30, 2013, FDA issued a Form 483 with 5 observations to American National Red Cross in Loveland, Colorado (FEI 1000148123) after an inspection that ran Aug 5 – Aug 30, 2013. The investigators were Andrea S. Heise, Andrew J. Gonzales, Kimberley A. Hoefeo, Marie B. Buen-Bigornia and Zachery L. Miller. Most observations concern laboratory controls and quality system.
At a glance
Laboratory controls and quality system account for 4 of 5 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards, sampling plans…
- 02
There is no quality…
- 03
Protective apparel is not worn as necessary to protect…
- 04
The written stability program for drug products does not include reliable, meaningful…
This inspection in context
Andrea S. Heise
1 document · 2013
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in Colorado.
The firmAmerican National Red Cross history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at American National Red Cross?
FDA listed 5 observations on this Form 483, mostly about laboratory controls, quality system and production. The opening words of each observation are shown on this page.
Who inspected American National Red Cross?
Andrea S. Heise, Andrew J. Gonzales, Kimberley A. Hoefeo, Marie B. Buen-Bigornia and Zachery L. Miller are named on this Form 483, for the inspection of Aug 5 – Aug 30, 2013. Each investigator has a profile showing what they cite most.
When was American National Red Cross inspected by FDA?
The inspection ran Aug 5 – Aug 30, 2013, and the Form 483 is dated August 30, 2013.
How do I get the full Form 483 for American National Red Cross?
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.