FDA Inspection
LCC Ltd.LCC Ltd. – FDA Inspection, Mar 22, 2024
Record Details
This FDA Inspection record concerns LCC Ltd., with an inspection on March 22, 2024, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 7fcf0473-d635-48b9-ac05-58be1866c831
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1234178
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Enforcement
- Warning Letter
FDA Citations
11- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.198(b)(2)Complaint Investigation/Follow-Up Findings
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.137(a)Expiration date lacking
- 21 CFR 211.84(d)(2)Testing Each Component for Conformity with Specs
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.25(b)Supervisor Training/Education/Experience
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.67(b)(3)Cleaning SOPs/instructions
- 21 CFR 211.180(c)Records not made readily available to FDA
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Other FDA inspections of LCC Ltd.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| December 15, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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