OLIVE BRANCH NATURAL BODY CARE LLC – FDA Inspection, Apr 2, 2019

Record Details

This FDA Inspection record concerns OLIVE BRANCH NATURAL BODY CARE LLC, with an inspection on April 2, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.

Company: OLIVE BRANCH NATURAL BODY CARE LLC
Inspection Date: April 2, 2019
Product Type: Drugs
Office: Center for Drug Evaluation and Research
Person: Andrew K. Haack (FDA Associated Person)

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ID · 5f5a2ca4-c728-4db1-b02d-30a62192426a

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 1084822
FDA center: Human Drugs
Project area: Drug Quality Assurance
Outcome: Form 483 issued

FDA Citations

21 CFR 211.188Prepared for each batch, include complete information
21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
21 CFR 211.198(a)Complaint Handling Procedure
21 CFR 211.165(a)Testing and release for distribution
21 CFR 211.22(a)Lack of quality control unit
21 CFR 211.166(a)Lack of written stability program
21 CFR 211.80(a)Procedures To Be in Writing
21 CFR 211.170(b)(1)Retention time of reserve samples, in general

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FDA Inspection

OLIVE BRANCH NATURAL BODY CARE LLCApril 2, 2019