During a March 12 Food and Drug Administration (FDA) inspection at Production Systems, Inc. in Shoreview, the company received one citation, FDA website data shows.
The review entailed the following areas:
- Compliance: Devices
- Postmarket Assurance: Devices
FDA records indicate the citation concerned the documentation of one or more risk management processes in product realization.
The FDA regularly conducts inspections at sites nationwide to assess compliance with laws and regulations intended to enhance public health, with inspection findings published online.
As noted by the FDA, the agency monitors the production and distribution of human and animal drugs, biological products, medical supplies, and tobacco products to ensure safety and quality.
Information in this article was obtained from the U.S. Food and Drug Administration. The source data can be found here.
