One of my PCQI instructors reminded me that the "very small business" for the IA rule is sizable, so some people may be off the hook on all of this.
"For purposes of the IA rule, a very small business (including any subsidiaries and affiliates) is an entity that is averaging less than $10,000,000 in annual sales, adjusted for inflation, per year, during the 3-year period preceding the applicable calendar year in sales of human food plus the market value of human food manufactured, processed, packed, or held without sale (e.g., held for a fee). See the definition of “very small business” in 21 CFR 121.3."
And from one of the questions from one of their draft supplemental guidances (https://www.fda.gov/...135122/download)
"Can a facility that is a subsidiary meet the definition of “very small business” under part 121 even if its parent company is not a very small business? Yes. It is possible for a facility that is a subsidiary to be a very small business even if its parent company is not a very small business because not all human food sold or manufactured, processed, packed, or held without sale by the parent company is counted in a subsidiary facility’s calculation of whether it is a very small business. Specifically, a subsidiary facility only includes operations of the parent company in the calculation if the parent company is an affiliate of the subsidiary facility."
Anyway, I wanted to share since it might help.
Edited by tsebring, 25 February 2020 - 10:28 PM.