FDA Inspection
AIE Pharmacueticals, Inc.AIE Pharmacueticals, Inc. – FDA Inspection, Sep 17, 2021
Record Details
This FDA Inspection record concerns AIE Pharmacueticals, Inc., with an inspection on September 17, 2021, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.
- Company
- AIE Pharmacueticals, Inc.
- Inspection Date
- September 17, 2021
- Product Type
- Food/cosmetics
View Company Profile
ID · 0b1d963a-d562-4d1b-a8a7-42096bcb6792
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1153103
- FDA center
- Foods & Cosmetics
- Project area
- Food Composition, Standards, Labeling and Econ
FDA Citations
8- 21 CFR 111.70(b)(1)Specifications - component identity
- 21 CFR 111.70(b)(2)Specifications-component purity, strength, composition
- 21 CFR 111.70(e)Specifications - identity, purity, strength, composition
- 21 CFR 111.103Written procedures - quality control operations
- 21 CFR 111.365Manufacturing operations - prevent contamination
- 21 CFR 111.255(b)Batch record - complete
- 21 CFR 111.205(b)(1)Master manufacturing record - specifications; quality
- 21 CFR 111.83(b)(1)Reserve sample -container-closure system
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Other FDA inspections of AIE Pharmacueticals, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 12, 2018 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
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