The Food and Drug Administration (FDA) issued five citations to Iso-Tex Diagnostics, Inc. in Alvin during a Feb. 3 Drug Quality Assurance inspection, according to data posted on the FDA’s website.
According to the FDA, the company received citations for the following:
- ‘The responsibilities and procedures applicable to the quality control unit are not fully followed.’
- ‘Buildings used in the manufacturing, processing, packing and holding of a drug product are not maintained in a good state of repair.’
- ‘Routine inspection and checking of automatic and mechanical equipment is not performed according to a written program designed to assure proper performance.’
- ‘Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not followed.’
- ‘The calibration of instruments and recording devices is not done at suitable intervals in accordance with an established written program.’
The FDA conducts regular inspections of facilities nationwide to ensure workplaces and products comply with FDA-regulated laws and regulations intended to protect public health. Results of these inspections are released to the public.
According to its website, the FDA serves as the federal agency responsible for regulating the production and distribution of human and animal drugs, biological products, medical supplies and tobacco products to maintain safety and quality.
Information in this article was obtained from the U.S. Food and Drug Administration. The source data can be found here.
