Torn notebook with record of ‘deficiencies’, plastic bags filled with shreds of paperwork, failure to adequately investigate and address consumer complaints, are some of the major norm violations found by the USFDA at Cadila Healthcare’s two plants in Gujarat.
As per the the warning letter sent by the USFDA over the two plants, the inspectors identified significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals and deviations from CGMP for the manufacture of active pharmaceutical ingredients (APIs).
“These violations and deviations cause your drugs to be adulterated, the methods used in, or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with, CGMP,” USFDA noted.
Recounting specific norm violations in the two plants, the USFDA said: “Our investigators found several plastic bags filled with paperwork and other scrapped items in the scrap yard. One item was a torn notebook of deficiencies recorded during review of your batch manufacturing records.”
The USFDA said during the inspection it found that the company did not adequately investigate out-of-specification (OOS) laboratory test results.
“For example, the following OOS investigation reports associated with potency and content uniformity specifications for warfarin sodium, a narrow therapeutic index drug, failed to identify a root cause or provide adequate corrective actions,” it said.
Besides, USFDA said Cadila Healthcare failed to establish and follow adequate written procedures describing the handling of all written and oral complaints regarding a drug product.
“Our inspection found that your firm did not adequately investigate and address consumer complaints on multiple occasions. Over a three-year period, your firm received nine consumer complaints related to potential mix-ups among products produced at your facility,” it said in the letter addressed to Cadila Healthcare Chairman Managing Director Pankaj Patel.
Complaints were reported by different pharmacies and distributors, it added.
“During your investigations of these complaints, you documented that some of the mixed-up drugs were manufactured on adjacent equipment lines, but you never completed the root cause analysis,” FDA said.
Additionally, during the inspection the investigator noted that the company failed to file Field Alert Reports (FARs) with FDA in eight of these nine instances, it added.
The USFDA said “the company failed to establish written procedures to monitor the progress and control the performance of processing steps that may cause variability in the quality characteristics of your APIs” in its second plant.
Besides, the company failed to exercise sufficient controls over computerised systems to prevent unauthorised access or changes to data, the letter said.
Until the company completes all corrections and the USFDA has confirmed compliance with CGMP, the regulator may withhold approval of any new applications or supplements listing, it said.
The warning letter follows inspection of the two facilities between August 28-September 5 and December 1-6, 2015 respectively by FDA inspectors.
Cadila Healthcare shares today ended at Rs 319.30 apiece on the BSE, up 1.83 per cent from previous close.