CFR section

21 CFR 106.40(d): Controls to prevent adulteration caused by ingredients, containers, and closures

PART 106-INFANT FORMULA REQUIREMENTS PERTAINING TO CURRENT GOOD MANUFACTURING PRACTICE, QUALITY CONTROL PROCEDURES, QUALITY FACTORS, RECORDS AND REPORTS, AND NOTIFICATIONS · Subpart B-Current Good Manufacturing Practice

Key facts

Citation 21 CFR 106.40(d)
Section Controls to prevent adulteration caused by ingredients, containers, and closures
Part PART 106-INFANT FORMULA REQUIREMENTS PERTAINING TO CURRENT GOOD MANUFACTURING PRACTICE, QUALITY CONTROL PROCEDURES, QUALITY FACTORS, RECORDS AND REPORTS, AND NOTIFICATIONS
Subpart Subpart B-Current Good Manufacturing Practice
Subchapter 21 CFR B Food
Product types cited Food/Cosmetics
Regulation text (excerpt) (d) A manufacturer shall develop written specifications for ingredients, containers, and closures used in manufacturing infant formula and shall develop and follow written procedures to determine whether all ingredients, containers, and closures meet these specifications. When any specification is not met, an individual qualified by education, training, or experience shall conduct a documented review, shall determine whether a failure to meet such a specification could result in an adulterated…

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