Laboratorio Opoterapico Argentino S.A. – FDA Inspection, Nov 11, 2016

Record Details

This FDA Inspection record concerns Laboratorio Opoterapico Argentino S.A., with an inspection on November 11, 2016, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.

Company: Laboratorio Opoterapico Argentino S.A.
Inspection Date: November 11, 2016
Product Type: Food/cosmetics
Office: Center for Food Safety and Applied Nutrition
Person: Bing Lin (Investigator)

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ID · 1376a2b1-fd4d-40f8-b2df-68b0f557a2f8

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number: 993095
FDA center: Foods & Cosmetics
Project area: Foodborne Biological Hazards
Outcome: Form 483 issued

FDA Citations

21 CFR 110.10(b)(3)Not washed/sanitized when appropriate
21 CFR 110.35(d)Failure to clean - general
21 CFR 110.40(b)Seams on food contact surfaces
21 CFR 110.80(a)(5)Temperature and humidity
21 CFR 110.37(e)Running water at suitable temperature
21 CFR 110.37(b)(5)Backflow prevention

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FDA Inspection

Laboratorio Opoterapico Argentino S.A.November 11, 2016