§106.91. General quality control. — Inbound Citations

(i) The results of all quality control testing conducted in accordance with § 106.91(a) and (b) to verify that each nutrient required by § 107.100 of this chapter is present in each production aggregate of infant formula at the level required by § 107.100 of this chapter, and that all other nutrients added by the manufacturer are present at the appropriate level. The record of the results of the quality control testing shall include:

(A) A summary document identifying the stages of the manufacturing process at which the nutrient analysis for each required nutrient is conducted as required under § 106.91(a); and

(B) A summary document on the stability testing program conducted under § 106.91(b), including the nutrients tested and the frequency of nutrient testing throughout the shelf life of the product.

(a) A manufacturer shall control under a quarantine system designed to prevent use or distribution of each production aggregate of infant formula until it determines that the production aggregate meets all of the manufacturer's specifications, including those adopted to meet the standards of § 106.55 on microbiological contamination and of § 106.91(a) on quality control procedures, or until the documented review of the failure to meet any of the manufacturer's specifications finds that the failure does not result in, or could not lead to, adulteration of the product.

(i) The results of all quality control testing conducted in accordance with § 106.91(a) and (b) to verify that each nutrient required by § 107.100 of this chapter is present in each production aggregate of infant formula at the level required by § 107.100 of this chapter, and that all other nutrients added by the manufacturer are present at the appropriate level. The record of the results of the quality control testing shall include:

(A) A summary document identifying the stages of the manufacturing process at which the nutrient analysis for each required nutrient is conducted as required under § 106.91(a); and

(B) A summary document on the stability testing program conducted under § 106.91(b), including the nutrients tested and the frequency of nutrient testing throughout the shelf life of the product.

(7) If the manufacturer is requesting an exemption under § 106.91(b)(1)(ii), the manufacturer shall include the scientific evidence that the manufacturer is relying on to demonstrate that the stability of the new infant formula will likely not differ from the stability of formulas with similar composition, processing, and packaging for which there are extensive stability data.

(ii) The Food and Drug Administration will exempt the manufacturer from the requirements of paragraph (b)(1)(i) of this section if the manufacturer of a new infant formula requests an exemption and provides analytical data, as required under § 106.120(b)(7), that demonstrates that the stability of the new infant formula will likely not differ from the stability of formulas with similar composition, processing, and packaging for which there are extensive stability data. A manufacturer exempt from the requirements of paragraph (b)(1)(i) of this section would be required to test the first production aggregate according to the requirements of § 106.91(b)(2).