FDA Inspection
CTK OTC Laboratories LLCCTK OTC Laboratories LLC – FDA Inspection, Oct 22, 2018
Record Details
This FDA Inspection record concerns CTK OTC Laboratories LLC, with an inspection on October 22, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 9124f900-9a0c-4b53-985b-29c6fb5abe09
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1069380
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
11- 21 CFR 211.188Prepared for each batch, include complete information
- 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 211.42(b)Product flow through building is inadequate
- 21 CFR 211.22(c)Approve or reject procedures or specs
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.42(c)Defined areas of adequate size for operations
- 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 |
| March 8, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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