FDA warns Indian drugmakers over discarded records, dirty facilities
The US Food and Drug Administration, or FDA, just called out some Indian pharmaceutical plants for "serious" problems with their data records and hygiene.
Constance Richard-Math, the FDA's deputy country director in India, told an industry gathering in Mumbai that inspections found discarded documents and dirty facilities, raising questions about how safe these medicines really are.
Constance Richard-Math urges supply chain checks
Richard-Math urged companies to "look beyond the walls of your own facilities: know your suppliers, know your vendors, know who is operating within your supply chain," and check up on their suppliers too, since any weak link can affect medicine safety.
She stressed, "These may not be your facilities, but I would ask you to look beyond the walls of your own facilities: know your suppliers, know your vendors, know who is operating within your supply chain."