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GUIDANCE DOCUMENT

Guidance for Industry: Exempt Infant Formula Production April 2016

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2014-D-0044
Issued by:
Guidance Issuing Office
Human Foods Program

Current Good Manufacturing Practices (CGMPs), Quality Control Procedures, Conduct of Audits, and Records and Reports

This guidance is intended to convey to industry the current thinking of the Food and Drug Administration (FDA or we) about the manufacturing of exempt infant formulas in relation to the requirements for current good manufacturing practices (CGMPs), quality control procedures, conduct of audits, and records and reports for nonexempt infant formulas in 21 CFR part 106.

FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe our current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in our guidances means that something is suggested or recommended, but not required.

Download the Guidance

Related Information

Submit Comments

Submit Comments Online

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2014-D-0044.

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