21 CFR 111.70(b) citations

Specifications - components

FDA investigators cited 21 CFR 111.70(b) 353 times at 343 facilities in the inspection citations FDA publishes, most recently in an inspection that ended Oct 15, 2026. A citation is an observation listed on Form FDA 483 at the end of an inspection; it is not a final agency decision.

Citations by fiscal year

FDA fiscal yearCitations
20272
2026172
2025158
202421

Recent citations

The latest inspections that cited this section. Facility names link to each facility's FDA record.

Inspection endedFacilityCountryObservation
Oct 15, 2026Nature's Value Inc.United StatesFor component(s) used in the manufacture of a dietary supplement, you did not establish identity specifications, necessary specifications to ensure the specifications for purity, strength, and composition of the dietary…
Oct 1, 2026Nutralife Biosciences, Inc.United StatesFor component(s) used in the manufacture of a dietary supplement, you did not establish identity specifications, necessary specifications to ensure the specifications for purity, strength, and composition of the dietary…
Sep 22, 2026Natural Solution Laboratories, Inc.United StatesFor component(s) used in the manufacture of a dietary supplement, you did not establish necessary specifications to ensure the specifications for purity, strength, and composition of the dietary supplement are met and…
Sep 22, 2026Remedy's Health Food, Inc.United StatesFor component(s) used in the manufacture of a dietary supplement, you did not establish identity specifications, necessary specifications to ensure the specifications for purity, strength, and composition of the dietary…
Sep 18, 2026NCAQCO, LLCUnited StatesFor component(s) used in the manufacture of a dietary supplement, you did not establish identity specifications, necessary specifications to ensure the specifications for purity, strength, and composition of the dietary…
Sep 17, 2026ADVANCED THERACEUTICALS, LLCUnited StatesFor component(s) used in the manufacture of a dietary supplement, you did not establish identity specifications, necessary specifications to ensure the specifications for purity, strength, and composition of the dietary…
Sep 17, 2026Synergy Health Laboratory Of FL LLCUnited StatesFor component(s) used in the manufacture of a dietary supplement, you did not establish identity specifications, necessary specifications to ensure the specifications for purity, strength, and composition of the dietary…
Sep 16, 2026Neolife International LLCUnited StatesFor component(s) used in the manufacture of a dietary supplement, you did not establish identity specifications.
Sep 16, 2026TAKA USA, INC.United StatesFor component(s) used in the manufacture of a dietary supplement, you did not establish identity specifications, necessary specifications to ensure the specifications for purity, strength, and composition of the dietary…
Sep 4, 2026Immune Tree, Inc.United StatesFor component(s) used in the manufacture of a dietary supplement, you did not establish identity specifications, necessary specifications to ensure the specifications for purity, strength, and composition of the dietary…
Sep 2, 2026BioCorp Nutrition LabsUnited StatesFor component(s) used in the manufacture of a dietary supplement, you did not establish identity specifications, necessary specifications to ensure the specifications for purity, strength, and composition of the dietary…
Aug 31, 2026GENVID LAB INC.United StatesFor component(s) used in the manufacture of a dietary supplement, you did not establish identity specifications, necessary specifications to ensure the specifications for purity, strength, and composition of the dietary…
Aug 28, 2026Ancient Formulas, Inc.United StatesFor component(s) used in the manufacture of a dietary supplement, you did not establish identity specifications, necessary specifications to ensure the specifications for purity, strength, and composition of the dietary…
Aug 28, 2026North American Herb And Spice Co. LTD, LLCUnited StatesFor component(s) used in the manufacture of a dietary supplement, you did not establish identity specifications, necessary specifications to ensure the specifications for purity, strength, and composition of the dietary…
Aug 28, 2026Sundance Botanicals, LLCUnited StatesFor component(s) used in the manufacture of a dietary supplement, you did not establish identity specifications, necessary specifications to ensure the specifications for purity, strength, and composition of the dietary…
Aug 27, 2026Karuna Kava And Tea LLCUnited StatesFor component(s) used in the manufacture of a dietary supplement, you did not establish identity specifications, necessary specifications to ensure the specifications for purity, strength, and composition of the dietary…
Aug 27, 2026RAPHA Health Network International, Inc.United StatesFor component(s) used in the manufacture of a dietary supplement, you did not establish identity specifications, necessary specifications to ensure the specifications for purity, strength, and composition of the dietary…
Aug 21, 2026KeyStone Co-Pack Manufacturing, LLCUnited StatesFor component(s) used in the manufacture of a dietary supplement, you did not establish identity specifications, necessary specifications to ensure the specifications for purity, strength, and composition of the dietary…
Aug 21, 2026Nature's Rite, LLCUnited StatesFor component(s) used in the manufacture of a dietary supplement, you did not establish identity specifications, necessary specifications to ensure the specifications for purity, strength, and composition of the dietary…
Aug 20, 2026Aspen Global LLCUnited StatesFor component(s) used in the manufacture of a dietary supplement, you did not establish identity specifications, necessary specifications to ensure the specifications for purity, strength, and composition of the dietary…
Aug 20, 2026Florida Supplement, LLC.United StatesFor component(s) used in the manufacture of a dietary supplement, you did not establish identity specifications, necessary specifications to ensure the specifications for purity, strength, and composition of the dietary…
Aug 20, 2026Personalized Nutrients LLCUnited StatesFor component(s) used in the manufacture of a dietary supplement, you did not establish identity specifications and necessary specifications to ensure the specifications for purity, strength, and composition of the…
Aug 19, 2026Oregons Wild Harvest IncUnited StatesFor component(s) used in the manufacture of a dietary supplement, you did not establish identity specifications and necessary specifications to ensure the specifications for purity, strength, and composition of the…
Aug 17, 2026Vitamin EnergyUnited StatesFor component(s) used in the manufacture of a dietary supplement, you did not establish identity specifications, necessary specifications to ensure the specifications for purity, strength, and composition of the dietary…
Aug 14, 2026GLOBAL WIDGET LLCUnited StatesFor component(s) used in the manufacture of a dietary supplement, you did not establish necessary specifications to ensure the specifications for purity, strength, and composition of the dietary supplement are met.

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Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.