FDA Inspection
Nots Co., LtdNots Co., Ltd – FDA Inspection, May 23, 2017
Record Details
This FDA Inspection record concerns Nots 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 · be096c5a-367b-43c5-adb3-a74b65804888
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1017841
- 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 211.125(b)Examination of issued labels
- 21 CFR 211.198(a)Procedures to be written and followed
- 21 CFR 211.130Procedures are written, and followed
- 21 CFR 211.125(a)Strict control not exercised over labeling issued
- 21 CFR 211.150(b)Distribution Recall System
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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