FDA Inspection 1158364 — Mclaughlin Gormley King Company

Mclaughlin Gormley King Company — FEI 2110594

The FDA completed an inspection of Mclaughlin Gormley King Company on Dec 8, 2021 in Chaska, MN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 2 citations were issued during this inspection. Product area: Drugs.

Inspection Details

Classification
Voluntary Action Indicated (VAI)
End Date
Dec 8, 2021
Fiscal Year
2022
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Chaska, MN (United States)

Citations

IDCFRDescription
121521 CFR 211.67(b)Written procedures not established/followed
430621 CFR 211.80(a)Written Procedures Not Followed