Teva Pharmaceutical Industries Ltd (NYSE:TEVA) has received a warning letter from the Food and Drug Administration (FDA), warning it that it needs to improve manufacturing standards at its sterile injectable plant in Hungary. Unlike on previous occasions where the agency ordered the company to shore up things at the plant, this time it has detailed the key problem areas that need to be worked on.
The warning letter follows a two-week FDA inspection of the facility earlier in the year where deficiencies in manufacturing operations and laboratory controls were discovered.