Kimberlee Trzeciak Deputy Commissioner for Policy, Legislation, and International Affairs of FDA | Official Website
Kimberlee Trzeciak Deputy Commissioner for Policy, Legislation, and International Affairs of FDA | Official Website
This is a 25% decrease from the number of companies cited in the previous quarter.
Of the 16 citations issued, the most common citation was 'Procedures describing the handling of written and oral complaints related to drug products are deficiently written or followed'.
Most of the companies cited were involved in the Devices sector.
Of the companies cited, two should take voluntary actions to correct their managing operations (66.7%). Additionally, one company had to take regulatory and/or administrative actions (33.3%).
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 |
|---|---|---|---|
| Med Pen Concepts, LLC | Devices | 01/24/2024 | Design verification - Lack of or inadequate procedures |
| Med Pen Concepts, LLC | Devices | 01/24/2024 | Design Validation - Risk analysis not performed/inadequate |
| Med Pen Concepts, LLC | Devices | 01/24/2024 | Design validation- Lack of or inadequate procedures |
| Med Pen Concepts, LLC | Devices | 01/24/2024 | Supplier notification of changes |
| Med Pen Concepts, LLC | Devices | 01/24/2024 | Lack of or inadequate process validation |
| Med Pen Concepts, LLC | Devices | 01/24/2024 | Incoming acceptance records, documentation |
| Med Pen Concepts, LLC | Devices | 01/24/2024 | Lack of or inadequate In-process acceptance procedures |
| Med Pen Concepts, LLC | Devices | 01/24/2024 | Lack of or inadequate final acceptance procedures |
| Med Pen Concepts, LLC | Devices | 01/24/2024 | Lack of or inadequate procedures |
| Med Pen Concepts, LLC | Devices | 01/24/2024 | DHR - not or inadequately maintained |
| Med Pen Concepts, LLC | Devices | 01/24/2024 | Complaints |
| Med Pen Concepts, LLC | Devices | 01/24/2024 | Sampling plans |
| Nasoya Foods USA, LLC | Food and Cosmetics | 03/04/2024 | Plant construction and design |
| Nasoya Foods USA, LLC | Food and Cosmetics | 03/04/2024 | Plant operations - Precautions |
| scPharmaceuticals, Inc. | Devices | 01/25/2024 | Complaint Handling Procedure |
| scPharmaceuticals, Inc. | Drugs | 01/25/2024 | Complaint Handling Procedure |
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