FDA Inspection
Time-Cap Laboratories, Inc.Time-Cap Laboratories, Inc. – FDA Inspection, Mar 12, 2018
Record Details
This FDA Inspection record concerns Time-Cap Laboratories, Inc., with an inspection on March 12, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · b0b1b9ee-20cf-445b-97b3-9d35ef75273e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1043706
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 211.28(a)Clothing appropriate for duties performed
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.160(b)(4)Establishment of calibration procedures
- 21 CFR 211.198(a)Procedures to be written and followed
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Time-Cap Laboratories, Inc.
12| Date | Classification | Office | Project area |
|---|---|---|---|
| April 24, 2025 | VAI | New York District Office | Drug Quality Assurance |
| October 10, 2023 | NAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| December 18, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 10, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 16, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Time-Cap Laboratories, Inc.
- FDA Inspection 1263597 - 2025-04-24
- FDA Inspection 1221504 - 2023-10-10
- FDA Inspection 1113101 - 2019-12-18
- FDA Inspection 963304 - 2016-03-10
- FDA Inspection 909667 - 2015-01-16
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