Benjamin D. Moncarz Chief Financial Officer - FDA | Official Website
Benjamin D. Moncarz Chief Financial Officer - 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 implement quality control operations to ensure the quality of the dietary supplement.
- You did not establish product specifications for limits on contamination that may adulterate, or that may lead to adulteration of, the finished dietary supplement.
- You did not establish product specifications for the identity, purity, strength and composition of the finished dietary supplement.
The company cited was involved in the Food and Cosmetics sector.
The company cited had to take regulatory and/or administrative actions.
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 |
---|---|---|---|
Spartan Enterprises, Inc. | Food and Cosmetics | 10/17/2023 | Quality control - quality, dietary supplement |
Spartan Enterprises, Inc. | Food and Cosmetics | 10/17/2023 | Specifications - contamination limits |
Spartan Enterprises, Inc. | Food and Cosmetics | 10/17/2023 | Specifications - identity, purity, strength, composition |
Spartan Enterprises, Inc. | Food and Cosmetics | 10/17/2023 | Component - verify identity, dietary ingredient |
Spartan Enterprises, Inc. | Food and Cosmetics | 10/17/2023 | Documentation - qualify supplier |
Spartan Enterprises, Inc. | Food and Cosmetics | 10/17/2023 | Components - quarantine |
Spartan Enterprises, Inc. | Food and Cosmetics | 10/17/2023 | Master manufacturing record - dietary ingredients |
Spartan Enterprises, Inc. | Food and Cosmetics | 10/17/2023 | Packaging description, representative label |
Spartan Enterprises, Inc. | Food and Cosmetics | 10/17/2023 | Instructions; specifications; quality |
Spartan Enterprises, Inc. | Food and Cosmetics | 10/17/2023 | Master manufacturing record - specific actions; quality |
Spartan Enterprises, Inc. | Food and Cosmetics | 10/17/2023 | Batch record - date, time; maintenance |
Spartan Enterprises, Inc. | Food and Cosmetics | 10/17/2023 | Batch record - component; identity, weight |
Spartan Enterprises, Inc. | Food and Cosmetics | 10/17/2023 | Batch record - results; monitoring |
Spartan Enterprises, Inc. | Food and Cosmetics | 10/17/2023 | Batch record - initials; verifying weight |
Spartan Enterprises, Inc. | Food and Cosmetics | 10/17/2023 | Batch record - initials; component |
Spartan Enterprises, Inc. | Food and Cosmetics | 10/17/2023 | Batch record - initials; verifying component |
Spartan Enterprises, Inc. | Food and Cosmetics | 10/17/2023 | Batch record - quality control review; production |