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21 CFR 111.70(b)(1) citations

Specifications - component identity

FDA investigators cited 21 CFR 111.70(b)(1) 490 times at 381 facilities in the inspection citations FDA publishes, most recently in an inspection that ended Jul 26, 2024. 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
202460
202341
202251
202124
202023
201938
201842
201733
201637
201529

Recent citations

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

Inspection endedFacilityCountryObservation
Jul 26, 2024Quantum Fulfillment And Support, LLCUnited StatesYou did not establish an identity specification for each component.
Jul 25, 2024Hyalogic LLCUnited StatesYou did not establish an identity specification for each component.
Jul 19, 2024PRC, IncUnited StatesYou did not establish an identity specification for each component.
Jul 12, 2024Country Life, LLCUnited StatesYou did not establish an identity specification for each component.
Jul 12, 2024NOVAREX CO LTD.Korea (the Republic of)You did not establish an identity specification for each component.
Jul 11, 2024Greenland IncUnited StatesYou did not establish an identity specification for each component.
Jul 10, 2024Al Global, Inc.United StatesYou did not establish an identity specification for each component.
Jun 25, 2024Aqua Nutraceuticals LLCUnited StatesYou did not establish an identity specification for each component.
Jun 14, 2024Pinnacle Labs International, Inc.United StatesYou did not establish an identity specification for each component.
Jun 14, 2024US FOOD MANUFACTURINGUnited StatesYou did not establish an identity specification for each component.
Jun 13, 2024Penn Herb Company, Ltd.United StatesYou did not establish an identity specification for each component.
Jun 7, 2024Mcclarry Innovation LLCUnited StatesYou did not establish an identity specification for each component.
May 31, 2024Natren Inc.United StatesYou did not establish an identity specification for each component.
May 28, 2024I AM WELL HOLISTIC INCUnited StatesYou did not establish an identity specification for each component.
May 24, 2024General Research LaboratoriesUnited StatesYou did not establish an identity specification for each component.
May 22, 2024Florida Nutrition Inc.United StatesYou did not establish an identity specification for each component.
May 17, 2024FCC Horiuchi Co., Ltd.JapanYou did not establish an identity specification for each component.
May 10, 2024Pro Line Nutrition LTD.CanadaYou did not establish an identity specification for each component.
Apr 26, 2024BodyBio Inc.United StatesYou did not establish an identity specification for each component.
Apr 22, 2024BF Suma Pharmaceuticals, Inc.United StatesYou did not establish an identity specification for each component.
Apr 22, 2024Enrinity Supplements, Inc.United StatesYou did not establish an identity specification for each component.
Apr 19, 2024High Five Drink Inc.United StatesYou did not establish an identity specification for each component.
Apr 5, 2024Empire Manufacturing, LLCUnited StatesYou did not establish an identity specification for each component.
Apr 5, 2024NATURE'S FUSIONS, LLCUnited StatesYou did not establish an identity specification for each component.
Apr 4, 2024Boxley Botanicals LLCUnited StatesYou did not establish an identity specification for each component.

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