FDA Warning Letter Goes to NJ Firm | Andres, Berger & Tran

The Food and Drug Administration is responsible for keeping tabs on a number of different types of dangerous problems and a New Jersey firm recently received an FDA warning letter dated in March. The pharmaceutical company affected by the FDA warning letter is Tris Pharma Inc. Investigators inspected the company’s location in Monmouth Junction, New Jersey and found problems with the manufacturing practices employed by the company.

Inspection Discovers Problems with Drug Manufacturing and Management

The inspection was carried out between mid-February and mid-March of 2017 and inspectors identified that the company did not properly establish quality control procedures that would identify problems or investigate failures within batches. The inspectors found that the company did not investigate defect complaints, testing failures, and product failures directly.

The preventive and corrective actions that the company should have deployed immediately after discovering these issues were allegedly not prompt or effective, according to the FDA. The agency requested that the company look at all of the various failures and conduct a reassessment associated with the quality of distributed batches. A number of different problems may be associated with the facility that does not properly implement and use these testing procedures. These testing procedures are often instrumental in identifying issues that could ultimately develop into side effects and problems in patients.

Hire a Drug Injury Lawyer in Haddonfield, NJ

An FDA warning letter is often sent to these companies in order to try to bring them into compliance sooner rather than later. If you believe you have grounds to pursue a defective drug lawsuit, you should contact the attorneys at Andres, Berger & Tran. Schedule a consultation today.

The articles on this blog are for informative purposes only and are no substitute for legal advice or an attorney-client relationship. If you are seeking legal advice, please contact our law firm directly.

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