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FDA Inspection
•Analytical Biochemistry Laboratories Inc. dba ABC Labs. Inc.•December 16, 2011

Analytical Biochemistry Laboratories Inc. dba ABC Labs. Inc. – FDA Inspection, Dec 16, 2011

Record Details

This FDA Inspection record concerns Analytical Biochemistry Laboratories Inc. dba ABC Labs. Inc., with an inspection on December 16, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
Analytical Biochemistry Laboratories Inc. dba ABC Labs. Inc.
Inspection Date
December 16, 2011
Product Type
Drugs
Office
Center for Drug Evaluation and Research
View Company Profile

ID · 0ecf742f-2d2d-4bfe-a93a-31dd8eed5c67

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
761235
FDA center
Human Drugs
Project area
Drug Quality Assurance

FDA Citations

3
  1. 21 CFR 211.58Buildings not maintained in good state of repair
  2. 21 CFR 211.25(a)Training--operations, GMPs, written procedures
  3. 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Analytical Biochemistry Laboratories Inc. dba ABC Labs. Inc.

4
DateClassificationOfficeProject area
November 14, 2017NAICenter for Drug Evaluation and ResearchDrug Quality Assurance
August 3, 2017Not classifiedKansas City District Office
March 3, 2015NAICenter for Veterinary MedicineMonitoring of Marketed Animal Drugs, Feed, and Devices
April 23, 2010NAICenter for Drug Evaluation and ResearchDrug Quality Assurance
Other documents for Analytical Biochemistry Laboratories Inc. dba ABC Labs. Inc.
  • FDA Inspection 1032230 - 2017-11-14
  • FDA Inspection 1029029 - 2017-08-03
  • FDA Inspection 917466 - 2015-03-03
  • FDA Inspection 658623 - 2010-04-23

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