Drugs

14 Intas Pharmaceutical Inspection Observations

FDA released the FDA-483 containing 14 observations from a 4/26-5/10 inspection at Intas Pharmaceutical, a Ahmedabad, Gujarat, India, biosimilar sterile drug manufacturer. The observations were:

laboratory records are deficient in that they do not include a complete record of all data obtained during testing;
appropriate controls are not exercised over computers or related systems, resulting in a failure to maintain a backup file of data entered into the computer or related system;
control records are deficient in that they are not an acceptable reproduction of the appropriate control records that is checked for accuracy, dated, and signed;
laboratory records do not include the initials or signature of a second person showing that the original records have been reviewed for accuracy, completeness, and compliance with established standards;
written records of investigations into unexplained discrepancies do not always include the conclusions and follow-up and extension to other batches;
control procedures are not established that validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product;
procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written, and followed;
laboratory controls do not include the establishment of scientifically sound and appropriate standards, sampling plans, and test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality, and purity;
the responsibility and procedures applicable to the quality control unit are not in writing and fully followed;
buildings used in the manufacturing, processing, packing, or holding of drug products are not free of infestation by birds;
cell banks were not maintained under appropriate storage monitoring conditions designed to maintain viability and prevent contamination and records of the use of the vials from the cell banks and storage conditions were not maintained;
procedures describing the calibration of instrument, apparatus, gauges, and recording devices are not written or followed;
the quality control unit lacks responsibility to approve all procedures or specifications affecting the quality of drug products; and
employees are not given training in the particular operation they perform as part of their function.

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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