Manna Omni International, Inc. – FDA Inspection, Dec 8, 2017

Record Details

This FDA Inspection record concerns Manna Omni International, Inc., with an inspection on December 8, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.

Company: Manna Omni International, Inc.
Inspection Date: December 8, 2017
Product Type: Drugs
Office: Center for Drug Evaluation and Research
Person: Linda Thai (FDA Associated Person)

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ID · f54d85fe-b1f8-4d9d-bc07-08e502e3e8d5

Inspection Facts

Official Action Indicated (OAI)

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

Inspection number: 1034621
FDA center: Human Drugs
Project area: Unapproved and Misbranded Drugs
Outcome: Form 483 issued

FDA Citations

21 CFR 211.198(a)Complaint Handling Procedure
21 CFR 211.166(a)Results not used for expiration dates, storage cond.
21 CFR 211.165(a)Testing and release for distribution
21 CFR 211.22(d)Procedures not in writing, fully followed

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FDA Inspection

Manna Omni International, Inc.December 8, 2017