Dr. Namandjé N. Bumpus Principal Deputy Commissioner - FDA | Official Website
Dr. Namandjé N. Bumpus Principal Deputy Commissioner - FDA | Official Website
This is an increase over the number of companies cited in the previous year.
The citations in the county include:
- Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity with all appropriate written specifications, without performing at least one specific identity test on each component and establishing the reliability of the supplier's analyses through appropriate validation of the supplier's test results at appropriate intervals.
- Written procedures are not drafted, reviewed and approved by the appropriate organizational units and reviewed and approved by the quality control unit.
- Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures designed to assure that components and drug products conform to appropriate standards of identity, strength, quality and purity.
The company cited was involved in the Drugs 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 |
|---|---|---|---|
| Fuller Industries, Inc. | Drugs | 02/17/2023 | Reports of Analysis (Components) |
| Fuller Industries, Inc. | Drugs | 02/17/2023 | Approval and review of procedures |
| Fuller Industries, Inc. | Drugs | 02/17/2023 | Scientifically sound laboratory controls |
| Fuller Industries, Inc. | Drugs | 02/17/2023 | Failing drug products not rejected |
| Fuller Industries, Inc. | Drugs | 02/17/2023 | Lack of written stability program |
| Fuller Industries, Inc. | Drugs | 02/17/2023 | Items to cover on annual reviews |
| Fuller Industries, Inc. | Drugs | 02/17/2023 | Description and Identification of Samples |
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