Live ChatLearn About Yaz Manufacturing Errors
In August of 2009, The FDA sent Bayer Healthcare, maker of Yaz, a warning letter outlining nonstandard, possibly deceptive testing procedures at its manufacturing plant in Germany. The violations were observed during an inspection of the facility.
According to the letter, Bayer had “significant deviations” from good manufacturing practices in the production of drospirenone, the progestin used in Yaz. The FDA indicated that Bayer had “averaged” test results, diluting out-of-specification results with those within established guidelines to get an acceptable result. This practice could have affected the quality and safety of the pills made with these batches of drospirenone.
Source:
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm182206.htm
[...] “specifications for the dosage of drospirenone” in the drugs. Last August, the FDA sent Bayer a warning letter over a similar issue, according to our YazTalk.com website. Oral contraceptives have been linked to [...]