FDA Inspection
INGENUE CAREINGENUE CARE – FDA Inspection, Dec 6, 2018
Record Details
This FDA Inspection record concerns INGENUE CARE, with an inspection on December 6, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 5bc040e7-6e78-47c3-9eff-8de11336d73f
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1073588
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
- Enforcement
- Warning Letter
FDA Citations
7- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.84(d)(3)Testing Containers & Closures Conformity with Specs
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.84(d)(1)Identity Testing of Each Component
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.22(a)Lack of quality control unit
- 21 CFR 211.166(a)Lack of written stability program
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