Dr. Christine S. Lee Acting Associate Commissioner for Minority Health and Director of the Office of Minority Health and Health Equity (OMHHE) in the Office of the Commissioner at the U.S. FDA | Official Website
Dr. Christine S. Lee Acting Associate Commissioner for Minority Health and Director of the Office of Minority Health and Health Equity (OMHHE) in the Office of the Commissioner at the U.S. FDA | Official Website
This is a 62.5% decrease from the number of companies cited in the previous year.
The citations in the county include:
- Procedures for rework of nonconforming product have not been adequately established.
- Procedures for corrective and preventive action have not been adequately established.
- Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been adequately established.
All of the companies cited were involved in either Devices, Food and Cosmetics, or Drugs sectors.
Of the companies cited, two should take voluntary actions to correct their managing operations (66.7%). Additionally, one company had to take regulatory and/or administrative actions (33.3%).
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 |
|---|---|---|---|
| Lohxa, LLC | Drugs | 08/03/2023 | Cleaning / Sanitizing / Maintenance |
| Lohxa, LLC | Drugs | 08/03/2023 | Absence of Written Procedures |
| Lohxa, LLC | Drugs | 08/03/2023 | In-process conformity - examination, sample testing |
| Lohxa, LLC | Drugs | 08/03/2023 | Accelerated stability studies |
| Lohxa, LLC | Drugs | 08/03/2023 | Batch production and Batch Control Record Requirements |
| Lohxa, LLC | Drugs | 08/03/2023 | Investigations of discrepancies, failures |
| Lohxa, LLC | Drugs | 08/03/2023 | Complaint Record at Location of Investigation |
| Plant Based Innovations, LLC | Food and Cosmetics | 07/14/2023 | Sanitary operations - Plant maintenance |
| Precision Optics Corporation, Inc. | Devices | 03/31/2023 | Product rework procedures, Lack of or inadequate procedures |
| Precision Optics Corporation, Inc. | Devices | 03/31/2023 | Lack of or inadequate procedures |
| Precision Optics Corporation, Inc. | Devices | 03/31/2023 | Lack of or inadequate complaint procedures |
Alerts Sign-up