FDA Inspection
Kdc US Holding Inc.Kdc US Holding Inc. – FDA Inspection, Feb 10, 2017
Record Details
This FDA Inspection record concerns Kdc US Holding Inc., with an inspection on February 10, 2017, issued by the Baltimore District Office, covering human drugs.
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ID · ea9a5aa7-9297-4985-98a2-0b0e6c0e2fc2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1025213
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
9- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.160(a)Deviations from laboratory control requirements
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.160(b)(3)Drug product sample
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.67(b)Written procedures not established/followed
- 21 CFR 211.68(b)Computer control of master formula records
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Other FDA inspections of Kdc US Holding Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 7, 2012 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Kdc US Holding Inc.
- FDA Inspection 797674 - 2012-09-07
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