FDA Inspection
Mediervas Industria de Produtos FarmaceuticosMediervas Industria de Produtos Farmaceuticos – FDA Inspection, Sep 13, 2019
Record Details
This FDA Inspection record concerns Mediervas Industria de Produtos Farmaceuticos, with an inspection on September 13, 2019, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.
- Inspection Date
- September 13, 2019
- Product Type
- Food/cosmetics
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ID · 7f9a7f8b-7b38-4797-ba74-f730f047e792
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1101923
- FDA center
- Foods & Cosmetics
- Project area
- Food Composition, Standards, Labeling and Econ
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 111.110Quality control operations - laboratory operations
- 21 CFR 111.135Quality control operations - product complaints
- 21 CFR 111.205(a)Master manufacturing record - each batch
- 21 CFR 111.260(c)Batch record - date, time; maintenance
- 21 CFR 111.260(j)(2)(iv)Batch record - initials; verifying component
- 21 CFR 111.260(k)(1)Batch record - identifier; packaging
- 21 CFR 111.35(b)(1)(ii)Procedures - equipment; calibrating, inspecting, checking
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