FDA Inspection
Cellex-C InternationalCellex-C International – FDA Inspection, Jan 17, 2012
Record Details
This FDA Inspection record concerns Cellex-C International, with an inspection on January 17, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Cellex-C International
- Inspection Date
- January 17, 2012
- Product Type
- Drugs
View Company Profile
ID · 3ffb2891-7590-474f-b511-be5541b34405
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 765438
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
4- 21 CFR 211.160(b)(3)Drug products - samples representative, identified properly
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.100(a)Approval and review of procedures
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