FDA Inspection
Loricon Analytical Testing LabLoricon Analytical Testing Lab – FDA Inspection, Apr 12, 2013
Record Details
This FDA Inspection record concerns Loricon Analytical Testing Lab, with an inspection on April 12, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- April 12, 2013
- Product Type
- Drugs
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ID · c8949718-09c4-4350-8b3f-c8efdb411f5e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 824876
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.194(c)Testing and standardization of standards et. al.
- 21 CFR 211.160(a)Lab controls established, including changes
- 21 CFR 211.194(a)(2)Suitability of testing methods verified
- 21 CFR 211.192Written record of investigation incomplete
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