Benjamin D. Moncarz Chief Financial Officer - FDA | Official Website
Benjamin D. Moncarz Chief Financial Officer - FDA | Official Website
This is a 25% increase over the number of companies cited in the previous year.
Of the 33 citations issued, the most common citation was 'You did not develop an FSVP'.
Most of the companies cited were involved in the Food and Cosmetics sector. The second most common type of company cited in the time period worked in the the Devices sector.
Of the companies cited, nine should take voluntary actions to correct their managing operations (90%). Additionally, one company had to take regulatory and/or administrative actions (10%).
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 |
---|---|---|---|
Austin's Natural Frozen Pops, Inc. | Food and Cosmetics | 10/24/2023 | Develop FSVP |
Austin's Natural Frozen Pops, Inc. | Food and Cosmetics | 10/24/2023 | Hazard analysis biological, chemical, physical |
Austin's Natural Frozen Pops, Inc. | Food and Cosmetics | 10/24/2023 | Document review entity's hazard analysis |
Austin's Natural Frozen Pops, Inc. | Food and Cosmetics | 10/24/2023 | Evaluation - performance, risk |
Austin's Natural Frozen Pops, Inc. | Food and Cosmetics | 10/24/2023 | Approved supplier procedures - importer established |
G Surgical, LLC | Devices | 03/01/2023 | Lack of or inadequate receiving acceptance procedures |
Luminex Corporation | Devices | 01/13/2023 | Individual Report of Malfunction |
Luminex Corporation | Devices | 01/13/2023 | Process changes - review, evaluation and revalidation |
Luminex Corporation | Devices | 01/13/2023 | Lack of or inadequate procedures |
Night Hawk Frozen Foods, Inc. | Food and Cosmetics | 05/23/2023 | Hazard analysis - Identification of hazard |
Night Hawk Frozen Foods, Inc. | Food and Cosmetics | 05/23/2023 | Allergen preventive controls - Appropriate (Adequate) |
Orange Traders, LLC | Food and Cosmetics | 04/11/2023 | Develop FSVP |
Orange Traders, LLC | Food and Cosmetics | 04/11/2023 | Identification - entry |
Organicare Nature's Science, LLC | Drugs | 12/01/2023 | Procedures not in writing, fully followed |
Organicare Nature's Science, LLC | Drugs | 12/01/2023 | Written procedures not established/followed |
Organicare Nature's Science, LLC | Drugs | 12/01/2023 | Written records kept in individual logs |
Shantaba, LLC | Food and Cosmetics | 07/07/2023 | Develop FSVP |
SpineSmith Holdings, LLC | Devices | 08/01/2023 | Quality Audit/Reaudit - conducted |
SpineSmith Holdings, LLC | Devices | 08/01/2023 | Training records |
SpineSmith Holdings, LLC | Devices | 08/01/2023 | Design validation - software validation not performed |
SpineSmith Holdings, LLC | Devices | 08/01/2023 | Software validation for automated processes |
SpineSmith Holdings, LLC | Devices | 08/01/2023 | Lack of or inadequate procedures |
SpineSmith Holdings, LLC | Devices | 08/01/2023 | Lack of or inadequate DHR procedures |
SpineSmith Holdings, LLC | Devices | 08/01/2023 | Evaluation, timeliness, identification |
Tiff's Treats RBD | Food and Cosmetics | 01/20/2023 | Qualifications of individuals |
Tiff's Treats RBD | Food and Cosmetics | 01/20/2023 | Sanitary operations - Plant maintenance |
Tiff's Treats RBD | Food and Cosmetics | 01/20/2023 | Manufacturing, processing, packing, holding - Controls |
Tiff's Treats RBD | Food and Cosmetics | 01/20/2023 | Process control - Foreign objects |
Westlake IVF, LLC | Biologics | 12/11/2023 | Responsible person to determine, document |
Westlake IVF, LLC | Biologics | 12/11/2023 | Statement re: certified testing lab |
Westlake IVF, LLC | Biologics | 12/11/2023 | Labeled re: biohazard, risks, test results |
Westlake IVF, LLC | Biologics | 12/11/2023 | Risk factors, clinical evidence |
Westlake IVF, LLC | Biologics | 12/11/2023 | Eligibility not required--warning labels |