FDA Inspection
Formulation Technology, Inc.Formulation Technology, Inc. – FDA Inspection, Jul 29, 2011
Record Details
This FDA Inspection record concerns Formulation Technology, Inc., with an inspection on July 29, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Formulation Technology, Inc.
- Inspection Date
- July 29, 2011
- Product Type
- Drugs
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ID · c400ad61-6af8-41f1-a4a3-62b31f189cc7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 734328
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.160(a)Lab controls established, including changes
- 21 CFR 211.186(b)(9)Manufacturing Instructions and Specifications
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.150Written distribution procedure
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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 | |
| November 9, 2023 | OAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| 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 |
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