Pharmaceutical Regulatory Affairs

FDA Warning Letter: Major CGMP Violations and Required Remediation

by

FDA Warning Letter: Major CGMP Violations and Required Remediation The FDA warning letter identifies significant violations of Current Good Manufacturing Practice (CGMP) requirements for finished pharmaceuticals. The FDA determined that the firm’s methods, facilities, and controls for manufacturing, processing, packing, or holding drugs did not conform to CGMP requirements under 21 CFR Parts 210 and … Read more

FDA Warning Letter: CGMP and Aseptic Processing Violations

by

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