FDA Inspection
Henan Kangdi Medical Devices Co. LtdHenan Kangdi Medical Devices Co. Ltd – FDA Inspection, Dec 14, 2016
Record Details
This FDA Inspection record concerns Henan Kangdi Medical Devices Co. Ltd, with an inspection on December 14, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · a7859e8b-7b97-4747-b796-746ed6a82bc3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 995883
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
13- 21 CFR 211.58Buildings not maintained in good state of repair
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.180(e)Records reviewed annually
- 21 CFR 211.89Quarantine of Rejected Components et. al.
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.42(c)(1)Incoming material area
- 21 CFR 211.188(b)Batch production and Batch Control Record Requirements
- 21 CFR 211.105(b)Distinctive ID or code not recorded in batch record
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Other FDA inspections of Henan Kangdi Medical Devices Co. Ltd
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 7, 2019 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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