Raw Material Testing

FDA Warning Letter: Major CGMP Violations and Required Remediation

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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: Major CGMP Violations in Raw Material Testing, Stability, Validation and Quality Systems

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FDA Warning Letter: Major CGMP Violations in Raw Material Testing, Stability, Validation and Quality Systems This FDA Warning Letter highlights significant violations of Current Good Manufacturing Practice (CGMP) requirements identified during an FDA inspection of a pharmaceutical manufacturing facility. The inspection found deficiencies involving raw material and API identity testing, supplier qualification, stability testing, Quality … Read more