There was one company in a city associated with Lycoming 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 unchanged from the number of companies cited in the previous year.
The citations in the county include:
- GMP training is not conducted on a continuing basis to assure that employees remain familiar with CGMP requirements applicable to them.
- There is a lack of written procedures assigning responsibility, providing cleaning schedules and describing in sufficient detail the methods, equipment and materials to be used for sanitation.
- Establishment of the reliability of the component supplier’s report of analyses is deficient in that the test results are not appropriately validated at appropriate intervals.
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 |
|---|---|---|---|
| Pace Analytical Services | Drugs | 05/23/2024 | GMP Training Frequency |
| Pace Analytical Services | Drugs | 05/23/2024 | Written sanitation procedures lacking |
| Pace Analytical Services | Drugs | 05/23/2024 | Establish reliability of supplier’s C of A |
| Pace Analytical Services | Drugs | 05/23/2024 | Lab controls established, including changes |
