FDA Inspection 1014194 — Accelerated Analytical Laboratories Inc.

Accelerated Analytical Laboratories Inc. — FEI 3006442227

The FDA completed an inspection of Accelerated Analytical Laboratories Inc. on May 12, 2017 in Milwaukee, WI. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 4 citations were issued during this inspection. Product area: Drugs.

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
May 12, 2017
Fiscal Year
2017
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Milwaukee, WI (United States)

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
189021 CFR 211.165(e)Test methods
203121 CFR 211.194(a)Complete test data included in records
360321 CFR 211.160(b)Scientifically sound laboratory controls