Smoke Study

FDA Warning Letter: Major Sterility, CAPA, Environmental Monitoring and CGMP Violations

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FDA Warning Letter: Major Sterility, CAPA, Environmental Monitoring and CGMP Violations The FDA Warning Letter reviewed in this article identifies significant Current Good Manufacturing Practice (CGMP) deficiencies at a pharmaceutical facility involved in the manufacture of sterile injectable drug products. The inspection was conducted under the authority of the U.S. Food and Drug Administration (FDA) … Read more

FDA Warning Letter: Major CGMP, Aseptic Processing and Microbiological Contamination Violations

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FDA Warning Letter: Major CGMP, Aseptic Processing and Microbiological Contamination Violations This FDA Warning Letter highlights significant violations of Current Good Manufacturing Practice (CGMP) requirements identified during an FDA inspection of a manufacturer of sterile prescription and over-the-counter (OTC) drug products. FDA determined that the firm’s manufacturing methods, facilities, and controls for manufacturing, processing, packing, … Read more

FDA Warning Letter: CGMP and Aseptic Processing Violations

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FDA Warning Letter: CGMP and Aseptic Processing Violations This FDA Warning Letter highlights significant regulatory and quality-system deficiencies identified during an FDA inspection of a facility producing compounded drug products. The FDA identified concerns involving Section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act), aseptic processing, sterile drug manufacturing, CGMP compliance, media … Read more