FDA Inspection
CTK OTC Laboratories LLCCTK OTC Laboratories LLC – FDA Inspection, Dec 31, 2024
Record Details
This FDA Inspection record concerns CTK OTC Laboratories LLC, with an inspection on December 31, 2024, issued by the Los Angeles District Office, covering human drugs.
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ID · 6d8511c0-096c-49e0-90f1-362217977bf5
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1257783
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
4- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.194(a)(2)Suitability of testing methods verified
- 21 CFR 211.110(a)Written in-process control procedures
- 21 CFR 211.192No written record of investigation
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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 |
| March 8, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 22, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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