FDA Inspection
Gianluca Mech S.P.A.Gianluca Mech S.P.A. – FDA Inspection, Mar 18, 2017
Record Details
This FDA Inspection record concerns Gianluca Mech S.P.A., with an inspection on March 18, 2017, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.
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ID · efe0bf46-51de-4a5c-a9ec-df3f8f44c34e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1017026
- FDA center
- Foods & Cosmetics
- Project area
- Food Composition, Standards, Labeling and Econ
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 111.75(a)(1)(i)Component - verify identity, dietary ingredient
- 21 CFR 111.103Written procedures - quality control operations
- 21 CFR 111.70(b)(1)Specifications - component identity
- 21 CFR 111.70(b)(2)Specifications-component purity, strength, composition
- 21 CFR 111.70(b)(3)Specifications - contamination limits
- 21 CFR 111.70(e)Specifications - identity, purity, strength, composition
- 21 CFR 111.205(a)Master manufacturing record - each batch
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