FDA Inspection
Codel International Co., Ltd.Codel International Co., Ltd. – FDA Inspection, Aug 25, 2017
Record Details
This FDA Inspection record concerns Codel International Co., Ltd., with an inspection on August 25, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 7d843c76-489c-4753-98e3-aaff66ad7b45
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1022742
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 211.142(b)Storage under appropriate conditions
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.180(e)Records reviewed annually
- 21 CFR 211.180(c)Records not made readily available to FDA
- 21 CFR 211.166(a)Results not used for expiration dates, storage cond.
- 21 CFR 211.22(a)Contract drug products--lack of responsibility
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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