Management circumvents Quality Department in Deviation Classification - FDA Warning Letter
From 6 February to 15 March 2024, the FDA inspected the pharmaceutical manufacturing facility of Wittman Pharma, Inc. in Brooksville and found violations of Current Good Manufacturing Practices (CGMP) for finished drug products, which led to a number of quality risks for the manufactured products. The subsequent 483 letter from the FDA was inadequately responded to, so that the FDA now published the following Warning Letter. Number of deficiencies In summary, the following deficiencies were listed in the FDA's Warning Letter : 1. Failures in quality control (in accordance with 21 CFR 211.22) Quality assurance/quality control (QU) did not ensure that the products met the required identity, strength, quality and purity standards. Drug batches were released without proper product testing and, for example, in the case of colour-changed tablets, management bypassed QU responsibilities and downgraded deviation classifications to ‘minor’ without adequate investigation to eliminate the nee