FDA Inspection 784712 — Laleham Health & Beauty Limited

Laleham Health & Beauty Limited — FEI 3003276300

The FDA completed an inspection of Laleham Health & Beauty Limited on Mar 22, 2012 in Alton. 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). 4 citations were issued during this inspection. Product area: Drugs.

Inspection Details

Classification
Voluntary Action Indicated (VAI)
End Date
Mar 22, 2012
Fiscal Year
2012
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Alton (United Kingdom)

Citations

IDCFRDescription
181021 CFR 211.160(a)Lab controls established, including changes
202621 CFR 211.192Quality control unit review of records
357021 CFR 211.100(a)Approval and review of procedures
435221 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action