Mark Raza Principal Deputy Chief Counsel - FDA | Official Website
Mark Raza Principal Deputy Chief Counsel - FDA | Official Website
This is a 57.9% decrease from the number of companies cited in the previous year.
Of the 27 citations issued, the most common citations include:
- The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
- Control procedures are not established which 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.
- There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
Most of the companies cited were involved in either Drugs or Food and Cosmetics sectors.
Of the companies cited, seven should take voluntary actions to correct their managing operations (87.5%). Additionally, one company had to take regulatory and/or administrative actions (12.5%).
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 |
---|---|---|---|
Acella Pharmaceuticals, LLC | Drugs | 02/10/2023 | Approve or reject procedures or specs |
Acella Pharmaceuticals, LLC | Drugs | 02/10/2023 | Scientifically sound laboratory controls |
Acella Pharmaceuticals, LLC | Drugs | 02/10/2023 | Investigations of discrepancies, failures |
Acella Pharmaceuticals, LLC | Drugs | 02/10/2023 | Procedures to be written and followed |
Avanos Medical, Inc. | Devices | 12/15/2023 | Design Validation - Risk analysis not performed/inadequate |
Avanos Medical, Inc. | Devices | 12/15/2023 | Lack of or inadequate procedures |
Avanos Medical, Inc. | Devices | 12/15/2023 | Lack of or inadequate complaint procedures |
Avion Pharmaceuticals, LLC | Drugs | 11/08/2023 | Procedures not in writing, fully followed |
Avion Pharmaceuticals, LLC | Drugs | 11/08/2023 | Control procedures to monitor and validate performance |
Avion Pharmaceuticals, LLC | Drugs | 11/08/2023 | Investigations of discrepancies, failures |
Avion Pharmaceuticals, LLC | Drugs | 11/08/2023 | Returned drug procedures in writing and followed |
Dester Corporation | Food and Cosmetics | 03/23/2023 | Develop FSVP |
Dynamic Technical Formulations, LLC | Food and Cosmetics | 08/22/2023 | Specifications - component identity |
Dynamic Technical Formulations, LLC | Food and Cosmetics | 08/22/2023 | Specifications met - identity, purity, strength, composition |
Dynamic Technical Formulations, LLC | Food and Cosmetics | 08/22/2023 | Records - ret'nd dietary supplement: material review, dispos |
Kor- Chem, Inc. | Drugs | 05/05/2023 | Procedures not in writing, fully followed |
Kor- Chem, Inc. | Drugs | 05/05/2023 | Training--operations, GMPs, written procedures |
Kor- Chem, Inc. | Drugs | 05/05/2023 | Reports of Analysis (Components) |
Kor- Chem, Inc. | Drugs | 05/05/2023 | Control procedures to monitor and validate performance |
Kor- Chem, Inc. | Drugs | 05/05/2023 | Expiration date lacking |
Kor- Chem, Inc. | Drugs | 05/05/2023 | Scientifically sound laboratory controls |
Kor- Chem, Inc. | Drugs | 05/05/2023 | Microbiological testing |
Kor- Chem, Inc. | Drugs | 05/05/2023 | Specific information required in individual logs |
Kor- Chem, Inc. | Drugs | 05/05/2023 | Complete instructions, procedures, specifications et. al. |
Kor- Chem, Inc. | Drugs | 05/05/2023 | Investigations of discrepancies, failures |
O&M Halyard, Inc. | Devices | 04/27/2023 | Individual Report of Malfunction |
San Antonio Bakery Solutions, LLC | Food and Cosmetics | 03/15/2023 | Develop FSVP |