There were two companies in a city associated with Juniata County that received FDA citations as a result of two inspections conducted in the county throughout 2023, according to reports from the U.S. Food and Drug Administration (FDA).
This is a 100% increase over the number of companies cited in the previous year.
The citations in the county include:
- You did not establish and follow written procedures for determining personnel qualification requirements.
- The personnel you identified to perform quality control operations do not have the education, training or experience to perform the assigned functions.
- You did not establish and follow written procedures for quality control operations.
The companies cited were involved in either Food and Cosmetics or Veterinary sectors.
Both companies cited should take voluntary actions to correct their 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 |
|---|---|---|---|
| Diphasic Analyses, Inc. | Food and Cosmetics | 04/11/2023 | Written procedures – personnel qualifications |
| Diphasic Analyses, Inc. | Food and Cosmetics | 04/11/2023 | Personnel – quality control personnel – qualified |
| Diphasic Analyses, Inc. | Food and Cosmetics | 04/11/2023 | Written procedures – quality control operations |
| Diphasic Analyses, Inc. | Food and Cosmetics | 04/11/2023 | Quality control – supplier qualification |
| Diphasic Analyses, Inc. | Food and Cosmetics | 04/11/2023 | Quality control operations – finished batch, specifications |
| Diphasic Analyses, Inc. | Food and Cosmetics | 04/11/2023 | Written procedures – holding |
| Diphasic Analyses, Inc. | Food and Cosmetics | 04/11/2023 | Written procedures – product complaint |
| Wade Cleck, LLC | Veterinary | 03/28/2023 | Personnel – records – training |
