Source: https://www.mastercontrol.com/au/compliance/21-cfr-regulations/111/
Timestamp: 2020-05-25 06:13:01
Document Index: 250980412

Matched Legal Cases: ['art 111', 'art 111', 'art 111', 'art 11', 'art 111', 'art 111', 'art 111', 'art 111', 'art 111', 'art 111', 'art 111', 'art 820', 'art 11', 'art 606']

21 CFR Part 111 | MasterControl
Solutions to 21 CFR Part 111 Challenges
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The FDA 21 CFR Part 111 ruling addresses the quality of the manufacturing processes for dietary supplements and the accurate listing of supplement ingredients. It does not limit consumers' access to dietary supplements; nor does it address the safety of the dietary supplements ingredients, or their effects on health, when proper manufacturing techniques are used. The rule applies to all domestic and foreign companies that manufacture, package, label or hold dietary supplements, including those involved with testing, quality control, and dietary supplement distribution in the U.S.
FDA 21 CFR Part 111 - Sections 111.103 & 111.105 of subpart F
FDA 21 CFR Part 111 - Sections 111.12(c), 111.13 & 111.14(b) of subpart B
21 CFR Part 111 - Section 111.70(a) & sec. 111.70(c)2 of subpart E
21 CFR Part 111 - Section 111.570(b)2(ii) of subpart O
FDA 21 CFR Part 111 - Section 111.75 (i) of subpart E and Section 111.530 of subpart N
F 21 CFR Part 111 - Section 111.120(b) of subpart F
According to sec. 111.120(b) of subpart F, the quality control operations team must determine whether dietary supplement components, packaging, and labels conform to specifications established under sec. 111.70 (b) and (d) of Part E (which establishes component, labeling, and packaging specifications for ensuring the quality of a dietary supplement.
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