21 CFR Part 106 - Infant Formula Requirements: CGMP, Quality Control, Records and Reports

What it says

Infant formula manufacturers must follow current good manufacturing practice, including controls to prevent adulteration, quality control procedures, testing of ingredients and finished product, and audits, must demonstrate that the formula supports normal physical growth through quality factor requirements, and must keep records and make reports and notifications to FDA as required, including notification before marketing a new formula or changing an existing one.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• Infant formula is the sole source of nutrition for many infants, so manufacturing controls are stricter than for most other foods.
• Microbiological control, such as for Cronobacter and Salmonella, is a central concern in production and the plant environment.
• Changes to formulation or processing are tied to notification requirements, so change control has regulatory implications.

What FDA inspectors look for

• Whether controls prevent microbial and chemical contamination throughout production.
• Whether ingredient and finished product testing is performed and documented.
• Whether formula and process changes were assessed and notified as required.

Related regulations