Leah Hunter Commissioner for External Affairs (OEA) within the Office of the Commissioner at the U.S. Food and Drug Administration | Official Website
Leah Hunter Commissioner for External Affairs (OEA) within the Office of the Commissioner at the U.S. Food and Drug Administration | Official Website
This is an increase over the number of companies cited in the previous quarter.
The citations in the county include:
- You did not conduct required tests of representative samples of water used in infant formula manufacturing with sufficient frequency to ensure that the water meets the EPA's Primary Drinking Water regulations.
- You did not monitor the temperature in a thermal processing equipment at a frequency as is necessary to maintain temperature control.
- You did not clean, sanitize, and maintain equipment used in the manufacture of infant formula at regular 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.
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 |
---|---|---|---|
Nat2, Inc. | Food and Cosmetics | 05/20/2024 | Potable water - representative samples frequency |
Nat2, Inc. | Food and Cosmetics | 05/20/2024 | Thermal process - frequency, monitor temperature |
Nat2, Inc. | Food and Cosmetics | 05/20/2024 | Clean, sanitize, maintain equipment & utensils |
Nat2, Inc. | Food and Cosmetics | 05/20/2024 | System of process controls to prevent adulteration |
Nat2, Inc. | Food and Cosmetics | 05/20/2024 | Production aggregate sample - final stage, distribution |
Nat2, Inc. | Food and Cosmetics | 05/20/2024 | Production aggregate test - required nutrients |