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In certain situations, the agency may take other actions instead of, or concurrent with, a Warning Letter. For example: [3] The product is adulterated under Section 402(a)(3) or 402(a)(4) of the Act; There is a violation of cGMP; The product contains illegal pesticide residues; or; The product shows short contents, subpotency, or superpotency.
The FDA gave the company 15 working days to respond to the warning letter. This article originally appeared on Milwaukee Journal Sentinel: Brenntag Great Lakes receives FDA warning letter over ...
The following are settlements reached with US authorities against pharmaceutical companies to resolve allegations of "off-label" promotion of drugs. Under the Federal Food, Drug, and Cosmetic Act, it is illegal for pharmaceutical companies to promote their products for uses not approved by the Food and Drug Administration (FDA), and corporations that market drugs for off-label indications may ...
A product recall usually involves the following steps, which may differ according to local laws: [1] The business gathers information and analyses the problem. The affected products and batches, their locations within the supply chain, and probable causes of the problem are identified. Responsible authorities are informed of the issue and ...
A product change notification (PCN) is a document issued by a manufacturer to inform customers about a change to a mass-produced product or its manufacturing process. In the semi-conductor industry, the JEDEC standard J-STD-046 describes the requirements for product change notifications and examples of types of changes that should be notified.
A product defect is any characteristic of a product which hinders its usability for the purpose for which it was designed and manufactured.. Product defects arise most prominently in legal contexts regarding product safety, where the term is applied to "anything that renders the product not reasonably safe". [1]
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The Automatic Complaint-Letter Generator is a website that automatically generates complaint letters. The website was created by Scott Pakin in 1994. The website was created by Scott Pakin in 1994. It allows users to submit the name of the individual or company that the complaint is directed toward.