According to FDA regulations, drug products leaving these sites are adulterated. ‘Methods used in, or facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with, cGMP,’ reads a letter from FDA written on 22 October 2015.

FDA first alerted Sandoz to these cGMP violations in August 2014 and has now conducted a detailed review of the firm’s responses received between September 2014 and August 2015. The responses received from Sandoz over that time have been branded inadequate.

FDA has called on Sandoz to describe the ‘corrective actions’ they will take, such as contacting customers, recalling product, conducting additional testing and/or adding lots to stability programmes to assure stability, or monitoring complaints. FDA has also asked Sandoz to describe the ‘preventive actions’ they will take, such as revising procedures, implementing new controls, training or re-training personnel, or other steps to prevent the recurrence of cGMP violations, including breaches of data integrity.

Sandoz was given 15 working days from the receipt of this letter to notify FDA of the specific steps they have taken to ‘correct and prevent the recurrence of deviation’.

FDA has said it may withhold approval of any new applications or supplements which list Sandoz as a drug product manufacturer until all corrections are completed and the agency confirms corrections of the violations and compliance with cGMP.

FDA keeps a close eye on Indian drug manufacturing sites and is known to have banned 30 sites since 2013 [1, 2]. Further reports are in danger of damaging the reputation of the industry, an important supplier of more affordable generics.

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References
1.    GaBI Online - Generics and Biosimilars Initiative. FDA issues warning letters to Indian firms [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Dec 11]. Available from: www.gabionline.net/Policies-Legislation/FDA-issues-warning-letters-to-Indian-firms
2.    GaBI Online - Generics and Biosimilars Initiative. FDA issues more warnings to Indian firms [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Dec 11]. Available from: www.gabionline.net/Policies-Legislation/FDA-issues-more-warnings-to-Indian-firms

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