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Following an FDA inspection of its North Carolina facility that found inadequate personnel training, non-implementation of quality control procedures and scuttle fly larva on employee clothing, Shanghai-based CARsgen Therapeutics has been issued a Warning Letter. Read More
Failure to conduct complete testing on sterile injectables, falsified monitoring records of areas used for aseptic filling lines as well as falsified cleaning records are among the serious lapses documented in the FDA’s Aug. 15 Warning Letter to Eugia Pharma Specialties of Hyderabad, Telangana, India. Read More
This excerpt is from the management report titled “Managing Data and Documentation for FDA Inspections and Remote Assessments,” based on a webinar from FDAnews, A WCG Company. The presenter was David Chesney, a former director of the FDA’s San Francisco District Office who is now principal and general manager of DL Chesney Consulting. Read More
Velocity Pharma’s lack of oversight of the quality of the eye drops its contract manufacturer — Kilitch Healthcare India Limited who received its own Warning Letter for the eye drops — has earned it an FDA Warning Letter. Read More
Omega Tech Labs received an FDA Warning Letter for inadequate procedures to prevent microorganisms in its combination product and failure to meet water quality standards in manufacturing following a Jan. 17-22 inspection. Read More
This excerpt is from the management report titled “Managing Data and Documentation for FDA Inspections and Remote Assessments,” based on a webinar from FDAnews, a WCG Clinical company. The presenter was David Chesney, a former director of the FDA’s San Francisco District Office who is now principal and general manager of DL Chesney Consulting. Read More
This excerpt is from the management report titled “Managing Data and Documentation for FDA Inspections and Remote Assessments,” based on a webinar from FDAnews, A WCG Company. The presenter was David Chesney, a former director of the FDA’s San Francisco District Office who is now principal and general manager of DL Chesney Consulting. Read More
A Baxter Healthcare drug manufacturing plant in Marion, N.C., has been hit with another Form 483 after an FDA inspection early in the year revealed more deficiencies, including two that remain unresolved from prior inspections. Read More
This Q and A is from the management report titled “Managing Data and Documentation for FDA Inspections and Remote Assessments,” based on a webinar from FDAnews, A WCG Company. The presenter was David Chesney, a former director of the FDA’s San Francisco District Office who is now principal and general manager of DL Chesney Consulting. Read More
Brassica Pharma, a maker of sterile semi-solids, received an FDA Warning Letter for failure to test every batch for sterility as well as fabrication of test results for batches not tested, among other violations. Read More
In this edition of Quick Notes, we cover a workshop on psychedelics, regulations on substances of human origin, selection of the COVID-19 strain for the next vaccines and a 483 for Swiss company Lonza. Read More
The FDA significantly increased foreign inspections in fiscal 2023 while domestic inspections remained flat, according to the agency’s latest annual inspection report. Read More