Drugs

18 Observations on Lupin FDA-483

FDA has released the form FDA-483 issued following a 10/3-10/14 inspection at the Lupin drug substance and drug product manufacturing facility in Pune, Maharashtra, India. The specific observations were:

aseptic monitoring for fill line, filling and cleaning machine, is not adequate;
failing to make an adequate product evaluation and take remedial action where actionable microbial contamination was found to be present in an area classified by the company as Grade A;
aseptic processing areas are deficient regarding the system for monitoring environmental conditions;
protective apparel, such as head and face covering, was not worn as necessary to protect the drug product from contamination;
growth promotion testing of swabs used to collect environmental monitoring samples does not reflect routine incubation requirements for environmental monitoring samples;
a building and raw material in support of an unidentified drug substance intermediate and drug substance and product manufacture are not adequately controlled;
the qualified state of a manufacturing utility system is not maintained;
the qualification of a facility system for an unidentified drug product manufacture is deficient;
training to perform assigned functions in such a manner as to assure that the drug product has the safety, identity, strength, quality, and purity that it purports or is represented to possess is deficient;
procedures for decontamination of material and components going into the classified clean manufacturing rooms are not sufficient to prevent contamination;
specific identification tests are not conducted on components that have been accepted based on the supplier’s report of analysis;
the examination and testing of samples did not assure that the drug product and in-process material conformed to specifications;
the examination and testing of samples did not assure that the drug product and in-process material conformed to specifications;
failing to perform a thorough investigation, make a record of the conclusion, and follow up of an unexplained discrepancy or a failure of a lot or unit to meet any of its specifications;
an equipment system cleaning specification is inadequate;
the batch production and control records are deficient in that they do not include documentation of batch investigations performed;
standard operating procedures in support of manufacture are deficient or are not followed; and
equipment and a manufacturing area used in drug substance and drug product manufacture are not maintained in a good state of repair.

Earlier this month, FDA posted a Warning Letter that resulted from a 3/22-4/4 inspection at Lupin’s manufacturing facility in Palghar, Maharashtra, India.

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