Mylan Fails to Distinguish Itself from Subpar Indian Manufacturing Facilities

Mylan CEO Heather Bresch has stated that her company has one quality standard for both its US and Indian plants, her point being that her expectation is that Mylan’s Indian facilities will prove the exception to the rule as the FDA steps up inspections abroad and bans more Indian plants and products from the US. It remains to be seen whether this is wishful thinking or a correct forecast.

Besides the drug formulations named below, many new and continuing shortages may be expected based on this FDA warning letter. Bloomberg has a good synopsis of Mylan’s situation at three Bangalore manufacturing facilities the company acquired from Agila. Shortly before the acquisition, Agila had received an FDA warning about the same issues, and those problems remain uncorrected to date.

(In the following quote, I have placed links to American Society of Health-System Pharmacists shortage bulletins as of 20150819.)

Detecting sources of contamination during aseptic processing operations is critical to safeguard product sterility. In response to our inspection, you followed a Product Quality Assessment (PQA) protocol and found visible foreign particulate matter within your examined lots. In March and April, 2015, you voluntarily recalled seven “for Injection” lots of Gemcitabine 200 mg/vial, Gemcitabine 2g, Gemcitabine 1 g, Carboplatin 10 mg/mL, Methotrexate 25 mg/mL, and Cytarabine 20 mg/mL. In June, 2015, you expanded your recall to an additional eight lots of Gemcitabine and Methotrexate. However, other lots released into distribution may have been compromised by this manufacturing issue.

Mylan Laboratories Limited 8/6/15
www.fda.gov

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