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FDA Inspection
•Caribia, Inc•November 3, 2011

Caribia, Inc – FDA Inspection, Nov 3, 2011

Record Details

This FDA Inspection record concerns Caribia, Inc, with an inspection on November 3, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
Caribia, Inc
Inspection Date
November 3, 2011
Product Type
Drugs
Office
Center for Drug Evaluation and Research
View Company Profile

ID · ae4a83ff-9b96-4246-89c2-7e88efeac4c0

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number
752735
FDA center
Human Drugs
Project area
Drug Quality Assurance

FDA Citations

5
  1. 21 CFR 211.142(a)Quarantine - actual practice
  2. 21 CFR 211.25(a)Training--operations, GMPs, written procedures
  3. 21 CFR 211.160(b)(2)In process materials - conformance to written specs
  4. 21 CFR 211.100(a)Absence of Written Procedures
  5. 21 CFR 211.67(b)Written procedures fail to include

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Caribia, Inc

1
DateClassificationOfficeProject area
March 7, 2011NAICenter for Food Safety and Applied NutritionColors and Cosmetics Technology
Other documents for Caribia, Inc
  • FDA Inspection 712416 - 2011-03-07

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