The USFDA inspected Biocon's insulins facility in Johar, Malaysia last month
The USFDA, which inspected Biocon's insulins facility in Johar, Malaysia last month, has found certain deviations related to production, quality, lab controls and facility and equipment systems.
The facility was inspected between February 6 and February 15 as part of pre-approval inspection and was issued six Form 483 observations.
The Malaysian unit, run under the Mylan-Biocon partnership, is largely focused on insulin variants. Biocon and Mylan have together filed for USFDA approval of long acting Insulin Glargine from this facility.
USFDA inspectors issue observations on Form 483 at the end of the site inspection outlining any deviations of current good manufacturing practices. The company then will have to file its response in 15 days providing corrective and preventive action plan referred as CAPA.
If the company responds to the satisfaction, the USFDA issues an establishment inspection report (EIR) indicating closure of the inspection.
Biocon earlier said it is responding to the USFDA observations with a corrective and preventive action plan in a timely manner.
Out of six observations published by USFDA, two deal with production, two on quality systems, one each on laboratory controls and facility and equipment maintenance.
Following is the list of six observations:
Observation 1 - procedures designed to prevent microbiological contamination of drug products to be sterile are not established or followed;
Observation 2 - There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
Observations 3 - Investigations of an unexplained discrepancy did not extend to other batches of the same product or other drug products that may be associated with the specific failure or discrepancy.
Observation 4 - Written production and process control procedures are not followed in the execution of product and process control functions.
Observation 5 - Laboratory controls do not include the establishment of scientifically-sound and appropriate test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.
Observation 6 - Procedures for the cleaning and maintenance of equipment are deficient regarding inspection of the equipment for cleanliness immediately before use.
"The observations seem to be routine and no observation is related to the data integrity," said IIFL in its report.
"This was a pre-approval inspection for Insulin Glargine, which is under review in US. The drug is currently under 30 month stay, and hence, approval will only take place after two years. Thus, the inspection will not have any impact on the revenues," the report added.
Biocon’s Malaysia facility is Asia’s largest integrated insulin manufacturing facility. The facility has GMP certification from the European Medical Agency.
This facility is important for Biocon’s emerging market business, as company has drug filings underway from this facility and expects commercial supplies to emerging markets in FY18 and beyond.Shares of Biocon dropped 1.11 percent and were trading at Rs 588.35 on BSE at 11.15 am, while the benchmark Sensex gained 0.34 percent to 34,032.73 points.