DA, Elizabeth Jungman, J.D., M.P.H. Chief of Staff of the FDA | Official Website
DA, Elizabeth Jungman, J.D., M.P.H. Chief of Staff of the FDA | Official Website
This is unchanged from the number of companies cited in the previous year.
The citations in the county include:
- You did not make and keep written procedures for the responsibilities of the quality control operations.
- You did not establish and follow written procedures for holding and distributing operations.
- You did not make and keep records of written procedures for fulfilling requirements for returned dietary supplements.
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 |
---|---|---|---|
Bloomsbury Farm, LLC | Food and Cosmetics | 08/02/2023 | Corrective actions in the sampling plan |
Haelan Products, Inc. | Food and Cosmetics | 09/12/2023 | Records - quality control operations; responsibilities |
Haelan Products, Inc. | Food and Cosmetics | 09/12/2023 | Written procedures - holding |
Haelan Products, Inc. | Food and Cosmetics | 09/12/2023 | Records - returned dietary supplement: written procedures |
Haelan Products, Inc. | Food and Cosmetics | 09/12/2023 | Written procedures - product complaint; review, investigate |