NEW YORK (TheStreet) -- Opko Health (OPK) - Get Report stock is down by 8.67% to $10.06 in early-morning trading on Wednesday, after the FDA said it observed deficiencies at the company's third-party contract manufacturer.
The Miami-based healthcare company announced on Wednesday that the regulatory agency found deficiencies at the company's drug manufacturer during a field inspection. The FDA reported the deficiencies in response to Opko's New Drug Application for RAYALDEE, a treatment for stage 3 or 4 chronic kidney disease.
However, the FDA's observations of deficiencies were "not specific to RAYALDEE manufacturing," the company added. The manufacturer will "respond promptly" to the FDA, Opko said.
"The (complete response letter) did not cite any safety, efficacy or labeling issues with regard to RAYALDEE, nor did it request any additional studies to be conducted prior to FDA approval," Opko added.
Separately, recently, TheStreet Ratings objectively rated this stock according to its "risk-adjusted" total return prospect over a 12-month investment horizon. Not based on the news in any given day, the rating may differ from Jim Cramer's view or that of this articles's author.
TheStreet Ratings rates this stock as a "hold" with a ratings score of C-. The primary factors that have impacted our rating are mixed - some indicating strength, some showing weaknesses, with little evidence to justify the expectation of either a positive or negative performance for this stock relative to most other stocks. The company's strengths can be seen in multiple areas, such as its robust revenue growth, largely solid financial position with reasonable debt levels by most measures and compelling growth in net income. However, as a counter to these strengths, we find that the stock has had a generally disappointing performance in the past year.
You can view the full analysis from the report here: OPK