Below is the warning letter that FDA sent to Wockhardt for the same facility that the UK regulator MHRA banned the imports from in 2013. It looks like Wockhardt has had warning letters in 2006, 2008, 2010 and 2012 from either FDA or MHRA across its global facilities. A little bit of research would have saved investors a lot of pain.... (below is the performance of Wockhardt in the last 6 months)
We added Lupin to our portfolio in Jan 2013. Since then, it has gone up about 46%. Above, is the performance in the last six months
Below is the warning letter that FDA sent to Lupin in 2009. The charges seem to be serious. While the facility survived repeated re-inspections from FDA and MHRA, little information is available on how the culture in the plant was changed to be totally complaint now. There has not been many 483's or warning letters to Lupin since then.... but it is the nature of the letter below that continues to concern us....
We are carefully looking at the stock again. Permanent risk of capital is not a risk we are interested in.... The onus is on us to make sure that Lupin is not the next Ranbaxy or the next Wockhardt....
|Public Health Service|
Food and Drug Administration
A. Numerous boxes were observed containing production, control, or distribution records in the destruction area of a separate building (Plant [(b)(4)]). For example, one of these boxes contained a Batch Packing Record (BPR) for Ceftriaxone for Injection USP lOg, Batch Number[(b)(4)], dated August 25, 2008 and August 26, 2008 was awaiting destruction as observed by Investigator Goga. Refer to FDA Form 483, Observation #2.