FDA Inspection
CTK OTC Laboratories LLCCTK OTC Laboratories LLC – FDA Inspection, May 4, 2026
Record Details
This FDA Inspection record concerns CTK OTC Laboratories LLC, with an inspection on May 4, 2026, issued by the Los Angeles District Office, covering human drugs.
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ID · f0e2592c-f4bf-4597-8273-71ee8087ed80
Inspection Facts
- Inspection number
- 1316014
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.67(b)Written procedures not established/followed
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
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Other FDA inspections of CTK OTC Laboratories LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| December 31, 2024 | OAI | 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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