FDA Inspection
Formulation Technology, Inc.Formulation Technology, Inc. – FDA Inspection, Nov 9, 2023
Record Details
This FDA Inspection record concerns Formulation Technology, Inc., with an inspection on November 9, 2023, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.
- People
- Sparky L. Bartee
- Yen-Tso Kuo
View Company Profile
ID · d53e94a3-3da9-4b94-b125-014b24490f94
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1222833
- FDA center
- Foods & Cosmetics
- Project area
- Food Composition, Standards, Labeling and Econ
- Outcome
- Form 483 issued
- Enforcement
- Warning Letter
FDA Citations
10- 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 111.105(a)Quality control - processes, specifications, written procedures
- 21 CFR 111.105(a)Quality control - processes, specifications, 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
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Other FDA inspections of Formulation Technology, Inc.
7| Date | Classification | Office | Project area |
|---|---|---|---|
| March 21, 2025 | Not classified | San Francisco District Office | |
| January 10, 2020 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 24, 2019 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| August 23, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 18, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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