FDA Inspection
Bioanue Laboratories Inc.Bioanue Laboratories Inc. – FDA Inspection, Aug 24, 2012
Record Details
This FDA Inspection record concerns Bioanue Laboratories Inc., with an inspection on August 24, 2012, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.
- Company
- Bioanue Laboratories Inc.
- Inspection Date
- August 24, 2012
- Product Type
- Food/cosmetics
View Company Profile
ID · 98d3a509-db3e-4863-a139-222ad214d554
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 796841
- FDA center
- Foods & Cosmetics
- Project area
- Food Composition, Standards, Labeling and Econ
FDA Citations
10- 21 CFR 111.13(b)Supervisor - education, training
- 21 CFR 111.75(a)(1)(i)Component - verify identity, dietary ingredient
- 21 CFR 111.70(b)(2)Specifications-component purity, strength, composition
- 21 CFR 111.70(d)Specifications - labels, packaging
- 21 CFR 111.65Quality control - quality, dietary supplement
- 21 CFR 111.35(b)(3)Documentation - instruments, controls; calibrations
- 21 CFR 111.35(b)(2)Document-equipment date of use, maintain, clean, sanitize
- 21 CFR 111.75(a)(2)(ii)(A)Component - qualify supplier
- 21 CFR 111.255(b)Batch record - complete
- 21 CFR 111.123(a)(8)Quality control - finished batch, distribution
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