Zdrowie i gospodarka · 10/02/2014
Draft Guidance for Industry; Exempt Infant Formula Production: Current Good Manufacturing Practices, Quality Control Procedures, Conduct of Audits, and Records and Reports; Availability
The Food and Drug Administration (FDA or we) is announcing the availability of the draft guidance entitled "Guidance for Industry; Exempt Infant Formula Production: Current Good Manufacturing Practices (CGMPs), Quality Control Procedures, Conduct of Audits, and Records and Reports." The draft guidance, when finalized, will describe our current thinking on the manufacturing of exempt infant formula in relation to the requirements for CGMPs, quality control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 nonexempt infant formulas.