FDA Inspection
Formulation Technology, Inc.Formulation Technology, Inc. – FDA Inspection, Mar 21, 2025
Record Details
This FDA Inspection record concerns Formulation Technology, Inc., with an inspection on March 21, 2025, issued by the San Francisco District Office, covering human drugs.
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ID · acd3c691-fc77-48b9-a15c-66da45edbce8
Inspection Facts
- Inspection number
- 1264439
- FDA center
- Human Drugs
FDA Citations
8- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.180(e)(1)Review of representative number of batches
- 21 CFR 111.365(h)Mechanical steps - contamination
- 21 CFR 111.105(a)Quality control - processes, specifications, written procedures
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Other FDA inspections of Formulation Technology, Inc.
7| Date | Classification | Office | Project area |
|---|---|---|---|
| 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 |
| July 18, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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