21 CFR 111.70(e) citations

Specifications - identity, purity, strength, composition

FDA investigators cited 21 CFR 111.70(e) 1,462 times at 1,013 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
2026163
2025171
2024130
2023102
2022115
202166
202055
201991
201888

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 StatesYou did not establish product specifications for purity, strength and composition.
Oct 1, 2026Nutralife Biosciences, Inc.United StatesYou did not establish product specifications for identity, purity, strength, composition and limits on contamination.
Sep 22, 2026Natural Solution Laboratories, Inc.United StatesYou did not establish product specifications for identity, purity, strength, composition and limits on contamination.
Sep 22, 2026Remedy's Health Food, Inc.United StatesYou did not establish product specifications for identity, purity, strength, composition and limits on contamination.
Sep 18, 2026NCAQCO, LLCUnited StatesYou did not establish product specifications for identity, purity, strength and limits on contamination.
Sep 17, 2026Synergy Health Laboratory Of FL LLCUnited StatesYou did not establish product specifications for purity.
Sep 4, 2026Immune Tree, Inc.United StatesYou did not establish product specifications for purity and composition.
Sep 2, 2026BioCorp Nutrition LabsUnited StatesYou did not establish product specifications for identity, purity, strength, composition and limits on contamination.
Aug 31, 2026GENVID LAB INC.United StatesYou did not establish product specifications for identity, purity, strength and composition.
Aug 28, 2026Ancient Formulas, Inc.United StatesYou did not establish product specifications for identity, purity, strength, composition and limits on contamination.
Aug 28, 2026North American Herb And Spice Co. LTD, LLCUnited StatesYou did not establish product specifications for identity, purity, strength and composition.
Aug 28, 2026Sundance Botanicals, LLCUnited StatesYou did not establish product specifications for identity, purity, strength, composition and limits on contamination.
Aug 27, 2026Karuna Kava And Tea LLCUnited StatesYou did not establish product specifications for identity, purity, strength, composition and limits on contamination.
Aug 25, 2026Amazing Nutra Inc.United StatesYou did not establish product specifications for identity, purity, strength and composition.
Aug 25, 2026Organic By Nature, Inc.United StatesYou did not establish product specifications for identity, purity, strength and composition.
Aug 21, 2026Balassa Laboratories, IncUnited StatesYou did not establish product specifications for identity, purity, strength, composition and limits on contamination.
Aug 21, 2026KeyStone Co-Pack Manufacturing, LLCUnited StatesYou did not establish product specifications for identity, purity, strength, composition and limits on contamination.
Aug 21, 2026Nature's Rite, LLCUnited StatesYou did not establish product specifications for identity, purity, strength and limits on contamination.
Aug 20, 2026Aspen Global LLCUnited StatesYou did not establish product specifications for identity.
Aug 20, 2026Personalized Nutrients LLCUnited StatesYou did not establish product specifications for identity, purity, strength and composition.
Aug 19, 2026Daily Manufacturing, Inc.United StatesYou did not establish product specifications for identity, purity, strength, composition and limits on contamination.
Aug 17, 2026Vitamin EnergyUnited StatesYou did not establish product specifications for identity, purity, strength, composition and limits on contamination.
Aug 14, 2026SDC NutritionUnited StatesYou did not establish product specifications for identity, purity, strength, composition and limits on contamination.
Aug 13, 2026USA-AGP Pharma LLCUnited StatesYou did not establish product specifications for identity, purity, strength, composition and limits on contamination.
Aug 12, 2026Ele Chocolates, LLCUnited StatesYou did not establish product specifications for identity, purity, strength, composition and limits on contamination.

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Search every Form 483 citation by company with the FDA 483 search, see all frequently cited CFR sections, or check one supplier with the free FDA compliance check.

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