FDA Inspection
Calox IncCalox Inc – FDA Inspection, Oct 31, 2014
Record Details
This FDA Inspection record concerns Calox Inc, with an inspection on October 31, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Calox Inc
- Inspection Date
- October 31, 2014
- Product Type
- Drugs
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ID · ec627534-5764-4aaa-84ba-d9ed796c60e4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 903856
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
5- 21 CFR 211.46(b)Equipment for Environmental Control
- 21 CFR 211.188(b)(13)Results of drug product inspections and examinations
- 21 CFR 211.42(b)Adequate space lacking to prevent mix-ups and contamination
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.180(e)(2)Items to cover on annual reviews
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