FDA Inspection
Badger Botanicals LLCBadger Botanicals LLC – FDA Inspection, May 9, 2018
Record Details
This FDA Inspection record concerns Badger Botanicals LLC, with an inspection on May 9, 2018, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.
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ID · 7e67bde3-8fa1-4b06-90cc-392985eb0c87
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1049860
- FDA center
- Foods & Cosmetics
- Project area
- Food Composition, Standards, Labeling and Econ
- Outcome
- Form 483 issued
FDA Citations
12- 21 CFR 111.75(a)(1)(i)Component - verify identity, dietary ingredient
- 21 CFR 111.410(b)Label, packaging - discrepancies
- 21 CFR 111.70(e)Specifications - identity, purity, strength, composition
- 21 CFR 111.35(b)(2)Document-equipment date of use, maintain, clean, sanitize
- 21 CFR 111.535(b)(1)Records - returned dietary supplement: written procedures
- 21 CFR 111.180(b)(1)Written procedures - product received
- 21 CFR 111.475(b)(1)Written procedures - holding; distributing
- 21 CFR 111.570(b)(1)Written procedures - product complaint; review, investigate
- 21 CFR 111.255(a)Batch record - every batch
- 21 CFR 111.205(a)Master manufacturing record - unique formulation
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