Drugs

Violations at ZS Pharma Listed

FDA has released the FDA-483 issued at the end of a 1/18-1/30 inspection at ZS Pharma, a Coppell, TX, active pharmaceutical ingredient (API) manufacturer. Specific violations noted on the form include:

process validation procedures do not ensure the integrity of process validation, and the quality unit does not retain the authority to accept or reject batches conducted in accordance with process validation;
buildings, facilities, and equipment are not maintained to ensure the API’s identity, strength, quality, and purity;
the specification of a redacted item is not justified with regard to the manufacturing process of a redacted item;
proper controls are not exercised over computerized systems used for analytical testing to ensure drug products meet their specified quality attributes;
cleaning validation of the equipment used to manufacture API is not established to ensure that contamination that would alter the safety, identity, strength, quality, or purity of the drug product is prevented; and
the reliability of a specified test method to quantitate elemental composition of a redacted item has not been demonstrated.

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FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome