CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER B—FOOD FOR HUMAN CONSUMPTION (parts 100 to 191) > PART 106—INFANT FORMULA QUALITY CONTROL PROCEDURES > SUBPART B—Quality Control Procedures for Assuring Nutrient Content of Infant Formulas (§106.20 to §106.90) > 106.25—In-process control.

106.25—In-process control.

(a) For each infant formula, a master manufacturing order shall be prepared and approved by a responsible official of the manufacturer. The manufacturer shall establish a quality control system that assures and verifies the addition of each ingredient specified in the manufacturing order.
(b) Unless each batch of finished product is analyzed as specified in § 106.30(b)(1), the manufacturer shall analyze each in-process batch for:
(1) Solids;
(2) Protein, fat, and carbohydrates (carbohydrates either by analysis or by mathematical difference);
(3) The indicator nutrient(s) in each nutrient premix;
(4) Each nutrient added independently of nutrient premixes during formulation of the product, except for linoleic acid, vitamin D, vitamin K, choline, inositol, and biotin; and
(5) Solids or an appropriate nutrient to confirm proper dilution when final dilution is made after performance of the analyses in paragraph (b) (1) through (4) of this section.