FDA Inspection
TheYeon Co., LtdTheYeon Co., Ltd – FDA Inspection, May 23, 2017
Record Details
This FDA Inspection record concerns TheYeon Co., Ltd, with an inspection on May 23, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · f3d9531c-be28-41e4-bb17-ca493bd8325e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1011837
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 211.196Distribution Record Requirements
- 21 CFR 211.84(d)(2)Establish reliability of supplier"s C of A
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.22(a)Contract drug products--lack of responsibility
- 21 CFR 211.22(c)Approve or reject procedures or specs
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.84(d)(2)Establish reliability of supplier's C of A
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