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Centro de Mando de Inocuidad Alimentaria 15 elementos

Infant Formula Quality Control Checklist

Esta lista de verificación está en inglés.

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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