Suzanne Roosen Acting Director of the Office of Food Policy and Response (OFPR) | Official Website
Suzanne Roosen Acting Director of the Office of Food Policy and Response (OFPR) | Official Website
This is an increase over the number of companies cited in the previous year.
The citations in the county include:
- The organizational structure has not been adequately established and maintained to ensure that devices are produced in accordance with 21 CFR 820.
- Procedures for finished device acceptance have not been adequately established.
- Procedures for rework of nonconforming product have not been adequately established.
The company cited should take a voluntary action to correct its managing operations.
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.
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 quality, according to its website.
Company Name | Area of Business | Inspection Date | Issue Cited |
---|---|---|---|
Orchid Orthopedic Solutions Alabama, LLC | Devices | 06/15/2023 | Lack of or inadequate organizational structure |
Orchid Orthopedic Solutions Alabama, LLC | Devices | 06/15/2023 | Lack of or inadequate final acceptance procedures |
Orchid Orthopedic Solutions Alabama, LLC | Devices | 06/15/2023 | Product rework procedures, Lack of or inadequate procedures |