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If the firm markets other FDA-regulated products and the issue(s) affect marketed products—or the inspection extended to marketed products included on the FDA 483, then they may issue a Warning Letter These include the following statement: "Due to the deficiencies listed on the attached FDA 483 we are recommending to the center that approval ...
Form FDA 483. The U.S. Food and Drug Administration (FDA) is authorized to perform inspections under the Federal Food, Drug, and Cosmetic Act, Sec. 704 (21 USC §374) "Factory Inspection". [ 1] Form FDA 483, [ 2] "Inspectional Observations", is a form used by the FDA to document and communicate concerns discovered during these inspections.
Good documentation practice (recommended to abbreviate as GDocP to distinguish from "good distribution practice" also abbreviated GDP) is a term in the pharmaceutical and medical device industries to describe standards by which documents are created and maintained. While some GDocP standards are codified by various competent authorities, others ...
The Food and Drug Administration (FDA) sent warning letters to three infant formula manufacturers over violations of federal safety regulations, the agency announced Wednesday. ByHeart, Mead ...
When the FDA conducted an inspection of Baxter's Chinese heparin supplier, it found serious deficiencies at the facility, which the FDA detailed in a warning letter. The warning letter detailed that the company failed to monitor changes in the impurity profile of incoming heparin active raw material, to adequately investigate out-of ...
Brenntag Great Lakes, a Wauwatosa chemical company, has received an FDA warning letter alleging it produced hand sanitizer with the same equipment used for brake parts cleaner. Inspections at the ...
FDA Building 32 houses the Office of the Commissioner and the Office of Regulatory Affairs. The Office of Global Regulatory Operations and Policy (GO), also known as the Office of Regulatory Affairs (ORA), is the part of the U.S. Food and Drug Administration (FDA) enforcing the federal laws governing biologics, cosmetics, dietary supplements, drugs, food, medical devices, radiation-emitting ...
The drugmaker, which can't seem to get its act straight lately, last week received a warning letter from the U.S. Food and Drug Administration that it is illegally marketing two products. In a ...