Wednesday, March 27, 2019

Warning Letter of the Week: pesky mold edition

From a love note to the president of Mariposa Labs from the Division of Pharmaceutical Quality Operations IV:
2. Your firm failed to follow written procedures describing the handling of all written and oral complaints regarding a drug product (21 CFR 211.198). 
You did not adequately document multiple complaints of mold, chemical smell, and stinging for the [redacted] creams, a drug with labeled indications including use on “newborns” and on broken skin. For example, you received a complaint for mold contamination in [redacted] Cream (lot #5589). You recalled lot #5589 from your customer, and your investigation found 36 containers in that lot contaminated with mold. 
Your microbiological test results confirmed the mold to be [redacted]. Your investigation suspected [redacted] as a potential root cause. However, you lacked sufficient evidence to support this conclusion. You did not extend your investigation to determine if additional lots of [redacted] Cream or any of your other topical products may have been contaminated.
Yikes, mold just pops up everywhere...

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