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Exempt Infant Formula Production: Current Good Manufacturing Practices, Quality Control Procedures, Conduct of Audits, and Records and Reports; Guidance for Industry; Availability

The Food and Drug Administration (FDA or we) is announcing the availability of a guidance for industry entitled ``Exempt Infant Formula Production: Current Good Manufacturing Pr...

The Food and Drug Administration (FDA or we) is announcing the availability of a guidance for industry entitled ``Exempt Infant Formula Production: Current Good Manufacturing Practices (CGMPs), Quality Control Procedures, Conduct of Audits, and Records and Reports.'' The guidance describes our current thinking on the manufacturing of exempt infant formula in relation to the requirements for CGMPs, quality control procedures, conduct of audits, and records and reports that apply to non-exempt infant formulas.

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Federal Register Citation

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81 FR 22174

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“Exempt Infant Formula Production: Current Good Manufacturing Practices, Quality Control Procedures, Conduct of Audits, and Records and Reports; Guidance for Industry; Availability,” thefederalregister.org (April 15, 2016), https://thefederalregister.org/documents/2016-08684/exempt-infant-formula-production-current-good-manufacturing-practices-quality-control-procedures-conduct-of-audits-and-r.