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2016-04-15
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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
Rules and Regulations
D09002ee1bdc1cb99
D09002ee1bdc1cc96
United States
Department of Health and Human Services
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United States Government Agency or Subagency
United States
Food and Drug Administration
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United States Government Agency or Subagency
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.
81 FR 22174
https://www.govinfo.gov/app/details/FR-2016-04-15/2016-08684
2016-08684
fr15ap16-2
4164-01-P
Docket No. FDA-2014-D-0044
https://www.govinfo.gov/app/details/FR-2016-04-15/2016-08684
https://www.govinfo.gov/content/pkg/FR-2016-04-15/html/2016-08684.htm
https://www.govinfo.gov/content/pkg/FR-2016-04-15/pdf/2016-08684.pdf
2 p.
22174
22175
81 FR 22174
Code of Federal Regulations
Title 21 Part 106
21 CFR Part 106
Exempt Infant Formula Production: Current Good Manufacturing Practices, Quality Control Procedures, Conduct of Audits, and Records and Reports; Guidance for Industry; Availability; Federal Register Vol. 81, Issue
RULE
2016-08684
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. FDA-2014-D-0044
4164-01-P
2016-08684
Notification of 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 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.
Submit either electronic or written comments on FDA guidances at any time.
Carrie L. Assar, Center for Food Safety and Applied Nutrition (HFS-850), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-1453.
Guidance for Industry:
Exempt Infant Formula Production Current Good Manufacturing Practices, Quality Control Procedures, Conduct of Audits, and Records and Reports
,
http://www.fda.gov/FoodGuidances
http://www.fda.gov/regulatoryinformation/dockets/default.htm
http://www.regulations.gov
Federal Register
Vol. 81, no. 73
Office of the Federal Register, National Archives and Records Administration
2016-04-15
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347 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2016-04-15
P0b002ee18f33feac
0097-6326
0042-1219
0364-1406
769-004-00000-9
000582072
f:fr15ap16
https://www.govinfo.gov/app/details/FR-2016-04-15
https://www.govinfo.gov/content/pkg/FR-2016-04-15/pdf/FR-2016-04-15.pdf
https://www.govinfo.gov/content/pkg/FR-2016-04-15/xml/FR-2016-04-15.xml
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22173
22509
DGPO
2016-04-15
2023-04-29
FR-2016-04-15
machine generated
eng
FR
FR-2016-04-15
81
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