James “Jim” Sigg FDA\'s Deputy Commissioner for Operations and Chief Operating Officer | Official Website
James “Jim” Sigg FDA\'s Deputy Commissioner for Operations and Chief Operating Officer | Official Website
This is an increase over the number of companies cited in the previous month.
The citations in the county include:
- Procedures to ensure equipment is routinely calibrated have not been adequately established.
- Procedures have not been adequately established to control product that does not conform to specified requirements.
- Procedures for corrective and preventive action 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 |
---|---|---|---|
Summit Orthopedic Technologies, Inc. | Devices | 02/15/2024 | Calibration, Inspection, etc. Procedures Lack of or Inadequ |
Summit Orthopedic Technologies, Inc. | Devices | 02/15/2024 | Nonconforming product, Lack of or inadequate procedures |
Summit Orthopedic Technologies, Inc. | Devices | 02/15/2024 | Lack of or inadequate procedures |
Summit Orthopedic Technologies, Inc. | Devices | 02/15/2024 | Review and evaluation for investigation |