FDA Inspection
Aqualex Co., Ltd.Aqualex Co., Ltd. – FDA Inspection, Oct 20, 2023
Record Details
This FDA Inspection record concerns Aqualex Co., Ltd., with an inspection on October 20, 2023, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 1f598fe2-3304-4e44-8e3f-1109fb04a918
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1220911
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
- Enforcement
- Warning Letter
FDA Citations
12- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.67(c)Cleaning/maintenance records not kept
- 21 CFR 211.48(a)Plumbing System Defects
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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