21 CFR 211

FDA Warning Letter: Major Data Integrity, Aseptic Processing and CGMP Violations at Reliance Life Sciences

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FDA Warning Letter: Major Data Integrity, Aseptic Processing and CGMP Violations at Reliance Life Sciences The FDA Warning Letter concerning Reliance Life Sciences Private Limited, Navi Mumbai, India, highlights serious deficiencies in Current Good Manufacturing Practice (CGMP) compliance, laboratory data integrity, microbiological testing, aseptic processing, cleaning and maintenance, quality-unit oversight, and contamination control. The inspection … 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

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