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:
(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.