Gasco Industrial Corp. – FDA Inspection, Mar 31, 2010

Record Details

This FDA Inspection record concerns Gasco Industrial Corp., with an inspection on March 31, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.

Company: Gasco Industrial Corp.
Inspection Date: March 31, 2010
Product Type: Drugs
Office: Center for Drug Evaluation and Research

View Company Profile

ID · e87aaadb-f02d-4b19-97e7-3d9621cc7688

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number: 656129
FDA center: Human Drugs
Project area: Drug Quality Assurance

FDA Citations

21 CFR 211.105(a)Identification of containers, lines, equipment
21 CFR 211.137(a)Expiration date lacking
21 CFR 211.165(b)Microbiological testing
21 CFR 211.80(d)Status of Each Lot Identified
21 CFR 211.160(b)(3)Drug products-sampling procedures/specifications
21 CFR 211.198(a)Procedures to be written and followed
21 CFR 211.67(c)Cleaning/maintenance records not kept
21 CFR 211.68(a)Calibration/Inspection/Checking not done
21 CFR 211.100(a)Absence of Written Procedures
21 CFR 211.22(a)Lack of quality control unit

Showing 10 of 12 citations.

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Gasco Industrial Corp.

Date	Classification	Office	Project area
February 27, 2026	Not classified	San Juan District Office
December 8, 2023	OAI	Center for Drug Evaluation and Research	Drug Quality Assurance
October 18, 2022	OAI	Center for Drug Evaluation and Research	Drug Quality Assurance
February 13, 2019	VAI	Center for Food Safety and Applied Nutrition	Foodborne Biological Hazards
March 2, 2018	OAI	Center for Food Safety and Applied Nutrition	Food Composition, Standards, Labeling and Econ