Vid Desai FDA’s Chief Information Officer | Official Website
Vid Desai FDA’s Chief Information Officer | Official Website
This is an increase over the number of companies cited in the previous month.
The citations in the city include:
- Control procedures are not established which monitor the output and validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.
- Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not written and followed.
- Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that in-process materials and drug products conform to appropriate standards of identity, strength, quality and purity.
The company cited was involved in the Devices and Drugs sectors.
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 |
|---|---|---|---|
| Meridian Medical Technologies, Inc. | Devices | 06/05/2024 | Control procedures to monitor and validate performance |
| Meridian Medical Technologies, Inc. | Devices | 06/05/2024 | Procedures for sterile drug products |
| Meridian Medical Technologies, Inc. | Devices | 06/05/2024 | Scientifically sound laboratory controls |
| Meridian Medical Technologies, Inc. | Devices | 06/05/2024 | Acceptance criteria for sampling & testing |
| Meridian Medical Technologies, Inc. | Devices | 06/05/2024 | Investigations of discrepancies, failures |
| Meridian Medical Technologies, Inc. | Devices | 06/05/2024 | Design output - Lack of or inadequate procedures |
| Meridian Medical Technologies, Inc. | Devices | 06/05/2024 | Design validation - Risk analysis |
| Meridian Medical Technologies, Inc. | Devices | 06/05/2024 | Purchasing controls, Lack of or inadequate procedures |
| Meridian Medical Technologies, Inc. | Devices | 06/05/2024 | Lack of or inadequate procedures |
| Meridian Medical Technologies, Inc. | Drugs | 06/05/2024 | Control procedures to monitor and validate performance |
| Meridian Medical Technologies, Inc. | Drugs | 06/05/2024 | Procedures for sterile drug products |
| Meridian Medical Technologies, Inc. | Drugs | 06/05/2024 | Scientifically sound laboratory controls |
| Meridian Medical Technologies, Inc. | Drugs | 06/05/2024 | Acceptance criteria for sampling & testing |
| Meridian Medical Technologies, Inc. | Drugs | 06/05/2024 | Investigations of discrepancies, failures |
| Meridian Medical Technologies, Inc. | Drugs | 06/05/2024 | Design output - Lack of or inadequate procedures |
| Meridian Medical Technologies, Inc. | Drugs | 06/05/2024 | Design validation - Risk analysis |
| Meridian Medical Technologies, Inc. | Drugs | 06/05/2024 | Purchasing controls, Lack of or inadequate procedures |
| Meridian Medical Technologies, Inc. | Drugs | 06/05/2024 | Lack of or inadequate procedures |
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