FDA Inspection 1041019 — HF Acquisition Co LLC

HF Acquisition Co LLC — FEI 3014534

The FDA completed an inspection of HF Acquisition Co LLC on February 9, 2018 in Mukilteo, WA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Drugs.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
February 9, 2018
Fiscal Year
2018
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Mukilteo, WA (United States)

Citations

IDCFRDescription
154021 CFR 211.125(a)Strict control not exercised over labeling issued
241921 CFR 211.198(a)Complaint Handling Procedure