FDA Inspection
BioMatrix c/o Specialty Fulfilment CenterBioMatrix c/o Specialty Fulfilment Center – FDA Inspection, May 9, 2018
Record Details
This FDA Inspection record concerns BioMatrix c/o Specialty Fulfilment Center, with an inspection on May 9, 2018, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.
- Inspection Date
- May 9, 2018
- Product Type
- Food/cosmetics
- Person
- Lavender M. Huskey
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ID · 1c6ad5ba-95e3-45b7-8316-a94d6aa896c5
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1051831
- FDA center
- Foods & Cosmetics
- Project area
- Food Composition, Standards, Labeling and Econ
- Outcome
- Form 483 issued
FDA Citations
9- 21 CFR 111.75(a)(1)(i)Component - verify identity, dietary ingredient
- 21 CFR 111.16Written procedures - cleaning
- 21 CFR 111.553Written procedures - product complaint
- 21 CFR 111.70(e)Specifications - identity, purity, strength, composition
- 21 CFR 111.55Production, process controls - implement
- 21 CFR 111.65Quality control - quality, dietary supplement
- 21 CFR 111.75(a)(2)(ii)(A)Component - qualify supplier
- 21 CFR 111.75(c)Specifications met - verify; finished batch
- 21 CFR 111.105(g)Quality control - reserve samples
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Other FDA inspections of BioMatrix c/o Specialty Fulfilment Center
1| Date | Classification | Office | Project area |
|---|---|---|---|
| August 29, 2019 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
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