FDA Inspection
Cenalga, LLCFDA Inspection 1208783 - Cenalga, LLC - June 22, 2023
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Record Details
This FDA Inspection record concerns Cenalga, LLC, with an inspection on June 22, 2023, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.
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ID · eb3a6c5c-829e-4a21-bddc-93a4279a2967
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1208783
- FDA center
- Foods & Cosmetics
- Project area
- Foodborne Biological Hazards
- Outcome
- Form 483 issued
FDA Citations
16- 21 CFR 111.70(b)(1)Specifications - component identity
- 21 CFR 111.70(e)Specifications - identity, purity, strength, composition
- 21 CFR 111.103Written procedures - quality control operations
- 21 CFR 111.553Written procedures - product complaint
- 21 CFR 117.135(a)(1)Preventive controls - Implement (Limited Scope only)
- 21 CFR 111.535(b)(1)Records - returned dietary supplement: written procedures
- 21 CFR 111.255(a)Batch record - every batch
- 21 CFR 111.205(a)Master manufacturing record - each batch
- 21 CFR 111.103Written procedures - quality control operations
- 21 CFR 111.205(a)Master manufacturing record - each batch
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