The Food and Drug Administration (FDA) issued three citations to the Johns Hopkins University PET Center in Baltimore following a drug quality assurance inspection on April 19, 2024, according to data posted on the FDA’s website.
The FDA website indicates that the citations were delivered to the company as follows:
- ‘You did not oversee production operations in a manner to ensure that each PET drug meets the quality and purity characteristics that it is supposed to have.’
- ‘You did not examine and approve or reject components to ensure compliance with procedures and specifications affecting the identity, strength, quality, or purity of a PET drug.’
- ‘You did not implement procedures and document your activities in accordance with your procedures to ensure that all equipment is cleaned that could reasonably be expected to adversely affect the identity, strength, quality, or purity of a PET drug, or give erroneous or invalid test results when improperly used or maintained.’
The FDA routinely inspects facilities across the nation to determine if the workplace and their products are compliant with FDA-regulated laws and regulations implemented to improve overall public health. Inspection results are then disclosed publicly.
According to its website, the FDA is a government agency that is primarily responsible for monitoring the production and distribution of human and animal drugs, biological products, medical supplies and tobacco products for safety and quality.
Information in this article was obtained from the U.S. Food and Drug Administration. The source data can be found here.
