Wednesday, October 16, 2019

Warning Letter of the Week: gritty cracking edition

A missive from the Center for Drug Evaluation and Research to the Chairman & Managing Director of Glenmark Pharmaceuticals Limited in Mumbai, India: 
Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether the batch has already been distributed (21 CFR 211.192). Your firm failed to ensure your investigations identify appropriate root causes and you failed to implement sustainable corrective action and preventive action (CAPA). 
a. You failed to thoroughly investigate multiple complaints of grittiness for your topical [redacted] cream USP, [redacted]%. Since November 2017, you rejected 20 batches and received at least 38 complaints about product grittiness. Product grittiness has been an ongoing formulation issue since 2010 and was a deficiency cited in the previous inspection of your facility. You proposed specific remediation for this formulation issue in your response at that time. In your response to the most recent inspection, you stated that the product grittiness issue was remediated during product reformulation in November 2018. Your response is inadequate. You did not provide sufficient data to demonstrate the robustness of the new formulation... 
d. You failed to adequately investigate more than 70 consumer complaints associated with punctures, cracks, and holes in [redacted] for various drug products including, but not limited to, [redacted] ointment USP, [redacted]%, [redacted] cream USP, and [redacted] ointment USP, [redacted]%. Your investigations failed to adequately address the scope and cause of these serious container/closure system defects and evaluate other drug products that have similar manufacturing quality signals such as complaints, or that use the same supplier. 
In your response, you stated that the root cause for the complaints was improper “handling by folding and refolding of the [redacted]” by consumers. In addition, you stated that because the complaint rate is insignificant, there is no risk to marketed batches. However, you closed more than 50 of the complaints, without CAPA to prevent recurrence of similar quality defects.
I like the "blame the root cause on the customer" approach - that's a new one.  

1 comment:

  1. Outside pharma, it's pretty common to blame failures of lousy products on "user error."


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