FDA Releases Suven Life Sciences FDA-483

FDA has released the FDA-483 issued following a 2/5-2/15 inspection at Suven Life Sciences Limited, Telangana, India. The inspection observations were: 

•          appropriate controls are not exercised over computer or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel;
•          equipment and utensils are not cleaned and maintained to prevent contamination that would alter the safety, identity, strength, quality, or purity of the intermediates and active pharmaceutical ingredients manufactured;
•          manufacturing batch records are deficient;
•          procedures for sampling of raw materials were not followed;
• ·        label access is not controlled;
•          employees engaged in the manufacture, processing, packing, and holding of a drug product lack the training required to perform their assigned functions; and
•          the firm’s product quality reviews are deficient.