FDA Inspection 1076495 — Element Materials Technology Boston - Acton Inc.

Element Materials Technology Boston - Acton Inc. — FEI 1000148174

The FDA completed an inspection of Element Materials Technology Boston - Acton Inc. on January 15, 2019 in Acton, MA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Drugs.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
January 15, 2019
Fiscal Year
2019
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Acton, MA (United States)

Citations

IDCFRDescription
180921 CFR 211.160(a)Following/documenting laboratory controls