FDA Inspection 930773 — Pharbest Pharmaceuticals, Inc.

Pharbest Pharmaceuticals, Inc. — FEI 3005382247

The FDA completed an inspection of Pharbest Pharmaceuticals, Inc. on June 8, 2015 in Farmingdale, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Drugs.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 8, 2015
Fiscal Year
2015
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Farmingdale, NY (United States)

Citations

IDCFRDescription
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
179621 CFR 211.80(d)Identification of Each Lot in Each Shipment
430721 CFR 211.80(d)Status of Each Lot Identified
434221 CFR 211.142(b)Storage under appropriate conditions
435121 CFR 211.160(b)(3)Drug products - samples representative, identified properly