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FDA Inspection
•Advanced Testing Laboratory, Inc.•December 21, 2016

Advanced Testing Laboratory, Inc. – FDA Inspection, Dec 21, 2016

Record Details

This FDA Inspection record concerns Advanced Testing Laboratory, Inc., with an inspection on December 21, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
Advanced Testing Laboratory, Inc.
Inspection Date
December 21, 2016
Product Type
Drugs
Office
Center for Drug Evaluation and Research
Person
  • Lauren N. Howard (FDA Associated Person)
View Company Profile

ID · 308fb4e5-4b93-4a0b-90e5-0f482591aa35

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
997633
FDA center
Human Drugs
Project area
Drug Quality Assurance
Outcome
Form 483 issued

FDA Citations

4
  1. 21 CFR 211.182Specific information required in individual logs
  2. 21 CFR 211.194(a)Complete test data included in records
  3. 21 CFR 211.194(b)Test method modification records do not include
  4. 21 CFR 211.160(a)Lab controls established, including changes

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Advanced Testing Laboratory, Inc.

5
DateClassificationOfficeProject area
November 9, 2023VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
October 20, 2011NAICenter for Drug Evaluation and ResearchDrug Quality Assurance
April 7, 2011VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
July 28, 2010NAICenter for Drug Evaluation and ResearchDrug Quality Assurance
April 9, 2010OAICenter for Drug Evaluation and ResearchDrug Quality Assurance
Other documents for Advanced Testing Laboratory, Inc.
  • FDA Inspection 1222827 - 2023-11-09
  • FDA Inspection 750420 - 2011-10-20
  • FDA Inspection 718458 - 2011-04-07
  • FDA Inspection 673606 - 2010-07-28
  • FDA Inspection 655092 - 2010-04-09

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