The US health regulator has warned Gujarat-based Pan Drugs that it will withhold approval of any new applications from the company for violations of norms, including data manipulation and infestation by rodents, birds and insects in buildings at its Vadodara plant.
In a warning letter to Pan Drugs MD and Chairman Kamal Pandya, US Food and Drug Administration (USFDA) said the company’s “methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of the Federal Food, Drug, and Cosmetic Act…”
Stating that the USFDA has already placed the company on Import Alert on December 8, 2015, the letter said: “Until you correct all violations completely and we confirm your compliance with CGMP, FDA may withhold approval of any new applications or supplements listing your firm as a drug product manufacturer.”
The manufacturing norms violations cited by the USFDA included failure “to maintain the buildings used in the manufacture, processing, packing, or holding of a drug product in a clean and sanitary condition and to keep them free of infestation by rodents, birds, insects, and other vermin”.
The letter further said investigators observed mold-like substances on the walls of the company’s drug processing area, and accumulations of powder throughout the facility including gaps and holes in the walls of the facility around piping and air ducts.
The firm also failed to exercise appropriate controls over computer or related systems to assure that only authorised personnel institute changes in master production and control records, or other records, it added.
Moreover, the company’s quality unit failed to identify data integrity issues in 11 batch production records reviewed by FDA investigator.
“Your production manager admitted that he falsified the signatures of other employees in the ‘Prepared By’, ‘Reviewed By’, ‘Approved By,’ and ‘Authorized By’ sections,” the letter said.
Failure to correct these violations may also result in FDA continuing to refuse admission of articles manufactured at Pan Drugs, at the Vadodara facility into the US, it added.