FDA Inspection
MS BionicMS Bionic – FDA Inspection, Dec 5, 2016
Record Details
This FDA Inspection record concerns MS Bionic, with an inspection on December 5, 2016, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.
- People
- Ling-Yu L. Liu (Issuing Officer)
- Nicholas J. Lahey (Issuing Officer)
- Sundy V Sedwick (Issuing Officer)
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ID · f7adcf6d-0ba7-490e-834c-0f90f603a9b5
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 994008
- FDA center
- Foods & Cosmetics
- Project area
- Food Composition, Standards, Labeling and Econ
- Outcome
- Form 483 issued
FDA Citations
13- 21 CFR 111.75(a)(2)Appropriate tests, examinations; certificate of analysis
- 21 CFR 111.453Written procedures - holding
- 21 CFR 111.353Manufacturing operations - written procedures
- 21 CFR 111.70(b)(1)Specifications - component identity
- 21 CFR 111.70(b)(2)Specifications-component purity, strength, composition
- 21 CFR 111.70(b)(3)Specifications - contamination limits
- 21 CFR 111.70(e)Specifications - identity, purity, strength, composition
- 21 CFR 111.103Written procedures - quality control operations
- 21 CFR 111.155(d)(1)Components - identify lot produced
- 21 CFR 111.475(b)(2)Records - product distribution
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