DETROIT (AP) -- Generic drugmaker Caraco Pharmaceutical Laboratories Ltd. said Monday it received a warning letter from the Food and Drug Administration over quality-control issues.
The letter was issued as a follow-up to an FDA inspection of the company's Detroit manufacturing plant in May. Caraco said it had responded to observations made by the agency and took corrective actions. Additional letters to the agency also noted improvements.
The FDA has the authority to withhold approval of pending applications listing the Detroit plant as the manufacturer until the agency considers the company's response satisfactory. Caraco said it intends to respond to the FDA within 15 business days.
"The company is committed to working cooperatively and expeditiously with the FDA to resolve the matters indicated in its letter," the company said in a statement.
Shares of Caraco fell 68 cents, or 6.7 percent, to $9.49 in morning trading. The stock has traded between $7.35 and $18.70 over the last 52 weeks.
