US FDA Slams CTX Lifesciences Again For Lax Failure Investigations
The FDA wants to know why the API firm is still not getting to the root cause of manufacturing deviations.
You may also be interested in...
Data integrity failures are so yesterday. Now it’s all about poor investigations into out-of-specification results.
Particulates, sterility failures and basic GMP noncompliance loomed large in FDA warning letters and EU GMP noncompliance notices to Facta Farmaceutici, Porton Biopharma, Antibioticos do Brasil, Euro Far, Ningbo Zhixin Bird Clean-Care, CTX Lifesciences and Pharmco Laboratories posted online last month.
Site-based metrics praised; lot acceptance rates, invalidated OOS rates discouraged. Agency official admits some proposed metrics were “not the best.”