FDA Inspection
Nanda Co., Ltd.Nanda Co., Ltd. – FDA Inspection, Mar 31, 2017
Record Details
This FDA Inspection record concerns Nanda Co., Ltd., with an inspection on March 31, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · fa4fa83e-6b47-47f2-85b9-d80698f21c8b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1009120
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
11- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.198(a)Procedures to be written and followed
- 21 CFR 211.42(c)(1)Incoming material area
- 21 CFR 211.188(b)Batch production and Batch Control Record Requirements
- 21 CFR 211.150(b)Distribution Recall System
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.42(c)Defined areas of adequate size for operations
- 21 CFR 211.56(c)Written procedures lacking for use of pesticides etc.
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