FDA Inspection
ORI Bionature SDN BHDORI Bionature SDN BHD – FDA Inspection, Dec 19, 2018
Record Details
This FDA Inspection record concerns ORI Bionature SDN BHD, with an inspection on December 19, 2018, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.
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ID · 5bd6225f-a62f-4ea0-a94c-78a1ad45dfb3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1078187
- FDA center
- Foods & Cosmetics
- Project area
- Food Composition, Standards, Labeling and Econ
- Outcome
- Form 483 issued
FDA Citations
10- 21 CFR 111.70(b)(1)Specifications - component identity
- 21 CFR 111.70(e)Specifications - identity, purity, strength, composition
- 21 CFR 111.70(g)Specifications - finished packaging, labeling
- 21 CFR 111.535(b)(1)Records - returned dietary supplement: written procedures
- 21 CFR 111.255(c)Batch record - follow master
- 21 CFR 111.260(k)(2)Batch record - label
- 21 CFR 111.260(k)(1)Batch record - identifier; labels
- 21 CFR 111.205(b)(1)Master manufacturing record - specifications; quality
- 21 CFR 111.210(b)Master manufacturing record - list components
- 21 CFR 111.210(f)Master manufacturing record theoretical and expected yield
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Other FDA inspections of ORI Bionature SDN BHD
1| Date | Classification | Office | Project area |
|---|---|---|---|
| May 25, 2017 | OAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
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