FDA Inspection

Mappel Packaging Industry S.A.April 15, 2016

Mappel Packaging Industry S.A. – FDA Inspection, Apr 15, 2016

Record Details

This FDA Inspection record concerns Mappel Packaging Industry S.A., with an inspection on April 15, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.

Company: Mappel Packaging Industry S.A.
Inspection Date: April 15, 2016
Product Type: Drugs
Office: Center for Drug Evaluation and Research

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ID · 0b029080-6587-4512-89af-8845ba67c1e6

Inspection Facts

Official Action Indicated (OAI)

Significant objectionable conditions were found and regulatory or administrative action is recommended.

Inspection number: 968466
FDA center: Human Drugs
Project area: Drug Quality Assurance

FDA Citations

21 CFR 211.103Actual vs. theoretical yields not determined
21 CFR 211.100(b)Procedure Deviations Recorded and Justified
21 CFR 211.84(d)(1)Component identity verification
21 CFR 211.137(a)Expiration date lacking
21 CFR 211.194(a)Complete test data included in records
21 CFR 211.198(a)Procedures to be written and followed
21 CFR 211.113(a)Procedures for non-sterile drug products
21 CFR 211.165(a)Testing and release for distribution
21 CFR 211.165(e)Test methods
21 CFR 211.22(c)Approve or reject procedures or specs

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