The US Food and Drug Administration noted incomplete laboratory records among potential manufacturing violations it observed during an inspection of Sun Pharmaceutical Industries’ Dadra unit this month, according to an inspection report obtained by Bloomberg News. Other observations included failure to create accurate duplicates of key records, and to properly investigate drug batches that didn’t meet specifications, according to the FDA’s report, called a Form 483, obtained through a Freedom of Information request. Sun Pharma’s stock fell as much as 3% to Rs 636.60, the lowest intra-day level in more than two months, before trading at Rs 637.70 in Mumbai. Frederick Castro, a spokesman for Sun Pharma, declined to comment on the FDA’s observations.
Sun Pharma, India’s largest drugmaker, has been contending with increased scrutiny from US regulators that has constrained access to the market where it gets about half its sales, slowing revenue growth. Another Sun Pharma plant in Halol, Gujarat, remains under an FDA warning letter that prevents new product launches from that facility to the US A reinspection of the Halol plant last year produced 14 pages of new observations, including poorly designed tests and tardiness reporting results. Sun has said it is responding to those observations.
“They need to improve on the documentation aspect across their plants,” said Surya Patra, an analyst at PhillipCapital India Pvt. “But improving their documentation systems will not hamper their manufacturing activities, so their business is not likely to be hampered.” The observations at the Dadra and the Halol plants were of a similar nature, and don’t appear to be serious as they are procedural, he said. In March, Sun announced the FDA had lifted its import ban against a facility in Punjab which had been acquired with the 2015 purchase of Ranbaxy Laboratories. Dadra is a union territory in western India.
The FDA made 11 total observations on the plant. The remainder range from an instance where expired intermediate-stage drugs were stored with unexpired batches, to a quality control unit that lacked authority to review manufacturing records, to criticisms of the lighting, employee clothing and equipment maintenance schedules, according to the document. In explaining the observation of incomplete lab records the report says inspectors noticed a torn and discarded printout showing data which was not included in records of test data for a batch of medicine.
Inspectors also found an Excel spreadsheet on a shared computer network which was not included in official data elsewhere, and in another instance raw data was missing from some drug production activities, according to the report. The FDA’s website says that a Form 483 is issued to a company when inspectors note any conditions that may constitute violations of the Food, Drug, and Cosmetic Act. The agency also says that the report does not constitute a final decision of whether any regulations were violated. The FDA considers company responses and other documents before deciding what further action, if any, is appropriate after a Form 483.