Nature & Nature Co., Ltd. – FDA Inspection, Jun 29, 2018

Record Details

This FDA Inspection record concerns Nature & Nature Co., Ltd., with an inspection on June 29, 2018, issued by the Office of Inspections and Investigations, covering human drugs.

Company: Nature & Nature Co., Ltd.
Inspection Date: June 29, 2018
Product Type: Human Drugs
Office: Office of Inspections and Investigations
Person: Lucila B. Nwatu (FDA Associated Person)

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ID · a24560a1-dfad-4770-b1e5-200aba32e4f9

Inspection Facts

Official Action Indicated (OAI)

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

Inspection number: 1058056
FDA center: Human Drugs
Project area: Drug Quality Assurance
Outcome: Form 483 issued

FDA Citations

21 CFR 211.125(a)Strict control not exercised over labeling issued
21 CFR 211.188Prepared for each batch, include complete information
21 CFR 211.198(a)Procedures to be written and followed
21 CFR 211.22(a)Lack of quality control unit
21 CFR 211.25(a)Training--operations, GMPs, written procedures

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FDA Inspection

Nature & Nature Co., Ltd.June 29, 2018