FDA Inspection
Medico Labs, Inc.Medico Labs, Inc. – FDA Inspection, Oct 30, 2008
Record Details
This FDA Inspection record concerns Medico Labs, Inc., with an inspection on October 30, 2008, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Medico Labs, Inc.
- Inspection Date
- October 30, 2008
- Product Type
- Drugs
View Company Profile
ID · fb535f4c-5c03-4ba4-b70f-82dce8464275
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 545129
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
9- 21 CFR 211.165(f)Failing drug products not rejected
- 21 CFR 211.192Extent of discrepancy, failure investigations
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.22(a)Authority lacking to review records, investigate errors
- 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 211.192No written record of investigation
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