FDA Inspection
Klingensmith Healthcare, Inc.Klingensmith Healthcare, Inc. – FDA Inspection, Dec 16, 2010
Record Details
This FDA Inspection record concerns Klingensmith Healthcare, Inc., with an inspection on December 16, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- December 16, 2010
- Product Type
- Drugs
View Company Profile
ID · d78f5990-b56f-4b4e-a5a5-cf222560c061
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 703577
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
7- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.188(b)(12)Investigations made into any unexplained discrepancy
- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.180(c)Records not made readily available to FDA
- 21 CFR 211.80(a)Written Procedures Not Followed
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