![]() ” The other 5 warning letters identify the firm’s failure to furnish records after multiple records requests from FDA (see, e.g., Warning Letter to Daxal Cosmetics Private Limited). As a result of the cGMP issues identified, the 6 firms were placed on Import Alert 66-40, which requires detention of products from “a firm that is not operating in conformity with. Of the 11 warning letters, 6 of the warning letters identified cGMP issues in the records reviewed (see, e.g., Warning Letter to Suhan Aerosol). Remote review of records in lieu of an inspection is known as a “paper inspection” or, in FDA guidance, a “remote regulatory assessment.” ![]() The Secretary’s request shall include a sufficient description of the records requested. This section grants FDA the authority to request records regarding drug products remotely, without an on-site inspection:Īny records or other information that the Secretary may inspect under this section from a person that owns or operates an establishment that is engaged in the manufacture, preparation, propagation, compounding, or processing of a drug shall, upon the request of the Secretary, be provided to the Secretary by such person, in advance of or in lieu of an inspection, within a reasonable timeframe, within reasonable limits, and in a reasonable manner, and in either electronic or physical form, at the expense of such person. Section 704(a)(4) was added to the FDCA by the Food and Drug Administration Safety and Innovation Action (FDASIA) in July 2012. Instead, FDA issued a request for records pursuant to Section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act (FDCA). For each of these facilities, FDA did not conduct an on-site inspection of the facility prior to issuing the warning letter. On August 3rd, FDA issued 11 warning letters to foreign facilities registered as OTC drug manufacturers. ![]()
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