FDA warns PointCare over manufacturing
Claiming that the company’s manufacturing processes are not in compliance with the agency’s standards.In a letter dated June 14, the FDA says it inspected the company’s Marlborough, Mass., facilities between March 25 and April 28, and found that “the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the Current Good Manufacturing Practice (CGMP) requirements” of the agency. The FDA argues that the company’s in vitro diagnostics are regulated products because they seek to treat or diagnose a disease.
The FDA says that the company’s quality control processes and documentation is insufficient on several levels. For instance, the FDA notes that the company released three lots of a diagnostic product for distribution, even after two of the lots failed to meet the specifications.
The FDA said the company’s training, preventive and corrective methods were all inadequate.
The FDA said that an initial response to the warning letter was insufficient and that the company should detail how it plans to correct the deficiencies in its manufacturing processes within 15 days of receipt of the June 14 letter.
Failure to promptly correct these violations may result in regulatory actions including seizure, injunction and/or civil money penalties, the FDA warned.
PointCare markets a portable hematology instrument that tests patients to determine the efficacy of antiretroviral therapy in treating HIV/AIDS.
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Hewlett-Packard, a developer and manufacturer of computing, data storage, and networking hardware, designing software and delivering IT services, leases 25%, with a lease that expires in July 2016. Wellington Management, an investment management
In a letter dated June 14, the FDA says it inspected the company's Marlborough, Mass., facilities between March 25 and April 28, and found that “the methods used in, or the facilities or controls used for, their manufacture, packing, storage,
And then there's former clean-tech poster child Evergreen Solar of Marlborough, which has acknowledged that it may be close to failure because of major challenges to its business model. To some, all this might call into question the state's focus in
Meanwhile, in October last year, the Marlborough District Council commissioned the National Institute of Water and Atmospheric Research (Niwa) to create a management plan for the area. Landcare Trust regional co-ordinator for Nelson and Marlborough
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Historical reminiscences of the early times in Marlborough, Massachusetts, and prominent events from 1860 to 1910, including brief allusions to many individuals and an account of the celebration of the two hundred and fiftieth anniversary of the incorporation of the town
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