There was one company in a city associated with Sullivan County that received FDA citations as a result of one inspection conducted in the county throughout 2024, according to reports from the U.S. Food and Drug Administration (FDA).
This is an increase over the number of companies cited in the previous year.
The citations in the county include:
- Buildings used in the of a drug product are not maintained in a good state of repair.
- Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent malfunctions and contamination that would alter the safety, identity, strength, quality or purity of the drug product.
- Written procedures for cleaning and maintenance fail to include description in sufficient detail of methods, equipment and materials used.
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.
According to its website, 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.
| Company Name | Area of Business | Inspection Date | Issue Cited |
|---|---|---|---|
| Gregory Pharmaceutical Holdings, Inc. | Drugs | 09/20/2024 | Buildings not maintained in good state of repair |
| Gregory Pharmaceutical Holdings, Inc. | Drugs | 09/20/2024 | Cleaning / Sanitizing / Maintenance |
| Gregory Pharmaceutical Holdings, Inc. | Drugs | 09/20/2024 | Written procedures fail to include |
| Gregory Pharmaceutical Holdings, Inc. | Drugs | 09/20/2024 | Following/documenting laboratory controls |
| Gregory Pharmaceutical Holdings, Inc. | Drugs | 09/20/2024 | Complaint Investigation/Follow-Up Findings |
