FDA Inspection
Time-Cap Laboratories, Inc.Time-Cap Laboratories, Inc. – FDA Inspection, Jan 16, 2015
Record Details
This FDA Inspection record concerns Time-Cap Laboratories, Inc., with an inspection on January 16, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Time-Cap Laboratories, Inc.
- Inspection Date
- January 16, 2015
- Product Type
- Drugs
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ID · 51cc5eeb-85b2-47b0-a427-d9b62c099b2f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 909667
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
10- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.170(b)Drug product reserve containers
- 21 CFR 211.110(b)In-process materials specifications
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.42(b)Product flow through building is inadequate
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.67(b)Written procedures not established/followed
- 21 CFR 211.67(b)Written procedures fail to include
- 21 CFR 211.100(b)SOPs not followed / documented
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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 12, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 10, 2016 | 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 1043706 - 2018-03-12
- FDA Inspection 963304 - 2016-03-10
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