FDA Inspection
Aesthetic Plus Company LimitedAesthetic Plus Company Limited – FDA Inspection, Sep 15, 2023
Record Details
This FDA Inspection record concerns Aesthetic Plus Company Limited, with an inspection on September 15, 2023, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · c9ab41a9-a061-4e26-b997-149aac5002c6
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1217752
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
14- 21 CFR 211.84(d)(1)Component identity verification
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.160(b)(4)Instruments, apparatus, et. al. not meeting specs
- 21 CFR 211.180(e)(1)Review of representative number of batches
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.160(b)(4)Instruments, apparatus, et. al. not meeting specs
- 21 CFR 211.165(a)Testing and release for distribution
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