Dhaliwal Laboratories LLC – FDA Inspection, Dec 15, 2011

Record Details

This FDA Inspection record concerns Dhaliwal Laboratories LLC, with an inspection on December 15, 2011, issued by the Center for Devices and Radiological Health, covering devices.

Company: Dhaliwal Laboratories LLC
Inspection Date: December 15, 2011
Product Type: Devices
Office: Center for Devices and Radiological Health

View Company Profile

ID · 51a12b82-c795-49e9-a51d-2fe1d15ecf80

Inspection Facts

Official Action Indicated (OAI)

Significant objectionable conditions were found and regulatory or administrative action is recommended.

Inspection number: 754506
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices

FDA Citations

21 CFR 820.184DHR - not or inadequately maintained
21 CFR 211.105(a)Identification of containers, lines, equipment
21 CFR 211.188Prepared for each batch, include complete information
21 CFR 211.188(b)(8)Labeling control records including specimens or copies
21 CFR 211.80(d)Status of Each Lot Identified
21 CFR 211.84(a)Components withheld from use pending release
21 CFR 211.63Equipment Design, Size and Location
21 CFR 211.160(b)Scientifically sound laboratory controls
21 CFR 820.22Quality audits - Lack of or inadequate procedures
21 CFR 211.67(c)Cleaning/maintenance records not kept

Showing 10 of 20 citations.

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Dhaliwal Laboratories LLC

Date	Classification	Office	Project area
June 26, 2025	Not classified	Dallas District Office
February 7, 2023	VAI	Center for Veterinary Medicine	Monitoring of Marketed Animal Drugs, Feed, and Devices
April 25, 2019	VAI	Center for Veterinary Medicine	Monitoring of Marketed Animal Drugs, Feed, and Devices
December 20, 2017	VAI	Center for Veterinary Medicine	Monitoring of Marketed Animal Drugs, Feed, and Devices
June 14, 2016	VAI	Center for Veterinary Medicine	Monitoring of Marketed Animal Drugs, Feed, and Devices