Drugs

16 Observations on Lupin Unit FDA-483

FDA has released the form FDA-483 issued following an 11/13-11/21 inspection at the Lupin Unit 1 drug manufacturing facility in Pradesh, India. The form contains these 16 inspection observations:

failing to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications, whether or not the batch has been already distributed;
failing to exercise appropriate controls over computer or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel;
failing to establish written procedures for evaluations conducted at least annually to review records associated with a representative number of batches, whether approved or rejected;
failing to maintain for at least one year after the expiration date all records of production, control, distribution, components, and labeling associated with a batch of drug products;
equipment used in the manufacture, processing, packing, or holding of a drug product lack appropriate design to facilitate operations for its intended use for its cleaning and maintenance;
failing to perform routine calibration of automatic and mechanical equipment according to a written program designed to assure proper performance;
failing to place in writing and fully follow the responsibilities and procedures applicable to the quality control unit;
redacted dosage forms are manufactured within a Grade D (ISO 8) manufacturing area/environment;
investigations are inadequate to determine the root cause for the failure of a batch of intermediate or active pharmaceutical ingredient (API) to meet specifications, whether or not the batch has been already distributed;
critical process parameters identified in the manufacture of APIs and API intermediates are not appropriately (continually) monitored;
computer systems do not have sufficient controls to prevent unauthorized access or changes to data;
issues involving a redacted marketing complaint;
issues involving redacted validation batch production records;
concerns about a Good Engineering Practices training module;
a standard procedure for the preparation, approval, issue, and control of a Drawing Layout is silent on the content of the review and approval process; and
a redacted API is manufactured within a Grade D (ISO 8) manufacturing area/environment.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

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FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome