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Infant Formula Quality Control Checklist
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Assess compliance with FDA infant formula quality control procedures, covering nutrient requirements, quality control, microbiological testing for Cronobacter and Salmonella, and recordkeeping.
21 CFR 10621 CFR 107
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Current Good Manufacturing Practice
- Are current good manufacturing practices for infant formula established and followed? *
- Are controls in place to prevent adulteration during manufacturing, packaging, and storage? *
- Is a written plan describing quality control procedures maintained? *
Nutrient Requirements
- Does the formula contain nutrients at levels required by the infant formula nutrient specifications? *
- Are in-process and finished product nutrient levels verified through testing? *
- Are procedures in place to ensure nutrient stability through the end of shelf life? *
Microbiological Controls
- Is finished product tested for Cronobacter (Enterobacter sakazakii) and Salmonella before release? *
- Is an environmental monitoring program for Cronobacter and Salmonella implemented? *
- Is product prevented from release until microbiological test results confirm acceptability? *
Audits & Verification
- Are periodic audits conducted to verify compliance with the quality control procedures? *
- Is production testing conducted to ensure the formula meets requirements at each production aggregate? *
- Is a stability testing program in place to confirm shelf-life claims? *
Recordkeeping & Registration
- Are production and inspection records for each batch maintained? *
- Has the manufacturer registered and submitted required infant formula notifications to FDA? *
- Are records retained for the required period and available for FDA inspection? *
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