During a Feb. 11 inspection, Turnco Tool & Instrument, Inc. in Georgetown was cited twice by the Food and Drug Administration (FDA), FDA data show.
The inspection reviewed several areas:
- Compliance: Devices
- Postmarket Assurance: Devices
Citations issued to the company are listed on the FDA website as follows:
- ‘One or more processes for risk management in product realization have not been documented.’
- ‘Production controls do not include documentation of procedures and methods for the control of production.’
The FDA conducts routine inspections throughout the United States to check whether facilities and their products comply with FDA-regulated standards and laws intended to protect public health. Results are made available to the public.
The FDA’s website states that the agency is primarily responsible for overseeing the safety and quality of human and animal drugs, biological products, medical supplies, and tobacco products distributed and produced in the U.S.
Information in this article was obtained from the U.S. Food and Drug Administration. The source data can be found here.
