FDA Inspection
CTK OTC Laboratories LLCCTK OTC Laboratories LLC – FDA Inspection, Mar 8, 2019
Record Details
This FDA Inspection record concerns CTK OTC Laboratories LLC, with an inspection on March 8, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · a8c43d7f-718d-497c-83fd-b7bc2d44fed1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1081833
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.188(b)(12)Investigations made into any unexplained discrepancy
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.180(e)Records reviewed annually
- 21 CFR 211.67(b)Written procedures not established/followed
- 21 CFR 211.80(a)Written Procedures Not Followed
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Other FDA inspections of CTK OTC Laboratories LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| May 4, 2026 | Not classified | Los Angeles District Office | Drug Quality Assurance |
| December 31, 2024 | OAI | Los Angeles District Office | Drug Quality Assurance |
| October 22, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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