Jim Jones Deputy Commissioner for Human Foods of FDA | Official Website
Jim Jones Deputy Commissioner for Human Foods of FDA | Official Website
This is a 66.7% decrease from the number of companies cited in the previous quarter.
The citations in the county include:
- The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
- Your firm failed to establish written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess.
- Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not established, written and followed.
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 |
|---|---|---|---|
| LiquidCapsule Manufacturing, LLC | Drugs | 02/09/2024 | Procedures not in writing, fully followed |
| LiquidCapsule Manufacturing, LLC | Drugs | 02/09/2024 | Absence of Written Procedures |
| LiquidCapsule Manufacturing, LLC | Drugs | 02/09/2024 | Procedures for non-sterile drug products |
| LiquidCapsule Manufacturing, LLC | Drugs | 02/09/2024 | Expiration date lacking |
| LiquidCapsule Manufacturing, LLC | Drugs | 02/09/2024 | Acceptance criteria for sampling & testing |
Alerts Sign-up