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 33.3% decrease from the number of companies cited in the previous year.
The citations in the county include:
- Buildings used in the manufacture, processing, packing, or holding of a drug product do not have the suitable construction to facilitate cleaning, maintenance, and proper operations.
- Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
- Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room to produce aseptic conditions.
The companies cited were involved in either Drugs or Devices sectors.
Of the companies cited, one should take voluntary action to correct its managing operations (50%). Additionally, one company had to take regulatory and/or administrative actions (50%).
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 |
|---|---|---|---|
| Forcemech International, LLC | Devices | 04/06/2023 | Labeling inspection - UDI |
| Forcemech International, LLC | Devices | 04/06/2023 | DMR - not or inadequately maintained |
| Forcemech International, LLC | Devices | 04/06/2023 | Servicing - Lack of or inadequate procedures |
| Iso-Tex Diagnostics, Inc. | Drugs | 02/10/2023 | Buildings of Suitable Size, Construction, Location |
| Iso-Tex Diagnostics, Inc. | Drugs | 02/10/2023 | Environmental Monitoring System |
| Iso-Tex Diagnostics, Inc. | Drugs | 02/10/2023 | Cleaning System |
| Iso-Tex Diagnostics, Inc. | Drugs | 02/10/2023 | Washing and toilet facilities are deficient |
| Iso-Tex Diagnostics, Inc. | Drugs | 02/10/2023 | Cleaning / Sanitizing / Maintenance |
| Iso-Tex Diagnostics, Inc. | Drugs | 02/10/2023 | Procedures for sterile drug products |
| Iso-Tex Diagnostics, Inc. | Drugs | 02/10/2023 | Establishment of calibration procedures |
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