FDA Inspections and Better Process Control School Requirements
It is important that you meet the FDA’s training requirements when producing low-acid or acidified foods. What happens when you don’t? We have some sample notes from FDA inspections.
COMPANY 1
OBSERVATION
Operators of thermal processing systems and container closure inspections were not under the operating supervision of a person who attended and satisfactorily completed a school approved by the FDA Commissioner as required by 21 CFR 108.35(g).
We acknowledge your response indicates that two food handlers will attend this course. Please provide an update on course registration or completion. If the course has been completed, please provide associated certificates.
You also have the continued responsibility to use procedures to prevent further violations of the Act and all applicable regulations for the products you export to the U.S. We will verify the implementation and the adequacy of all your corrective actions during our next inspection.
COMPANY 2
OBSERVATION
Operators of retorts are not under the operating supervision of a person that has attended and satisfactorily completed, a school approved by the Commissioner. Specifically, your retort operator, your operators of the sealing machines nor anyone at the firm has attended and successfully completed a Better Processing Control School (BPCS) training approved by the Commissioner of FDA.
COMPANY 3
OBSERVATION
Operators of retorts, thermal processing systems, and container closure inspections were not under the operating supervision of a person who attended and satisfactorily completed a school approved by the FDA Commissioner. Specifically, I observed operators of retorts, thermal processing systems, and container closure inspections were not under the operating supervision of a person who attended and satisfactorily completed a school approved by the FDA Commissioner.
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