The warning letter, dated November 16, discusses the Indian drug firm’s response to an inspection last October when agency staff detected a number of violations of current good manufacturing practice (cGMP) at the facility.
The Food and Drug Administration (FDA) said Wockhardt’s response to the inspection – which it received late last year - was ‘inadequate’ and advised it to hire a consultant to help it bring the facility up to code.
Wockhardt acquired the facility in 2003 when it bought CP Pharmaceuticals.
Just last week the firm said it planned to build a sterile manufacturing and drug testing facility at its site in a $12.4m that will create 50 jobs
The firm did not respond to a request for comment.