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Warning Letter of the Week: dancing festival edition

Via a comment at In the Pipeline, this funny missive from the Center for Drug Evaluation and Research to the director of Centurion Laboratories Private Limited (emphasis mine):

3. Your firm failed to follow written procedures for cleaning and maintenance of equipment (21 CFR 211.67(b)). 

During the inspection, our investigator observed that equipment used to manufacture more than one product was inadequately maintained and cleaned. 

For example, our investigator observed in the [redacted] room a [redacted] identified as “cleaned.” However, this [redacted] was found to have visible product build-up inside the [redacted] and [redacted] of the [redacted]. Furthermore, the air filter of the equipment was damaged with multiple holes. This equipment was used to manufacture finished drug products shipped to the United States such as [redacted] tablets, [redacted] tablets, [redacted] tablets, and [redacted] tablets. Additionally, a memo provided during the inspection stated these cleaning and equipment maintenance deficiencies were because of a shortage in manpower related to a nine-day dancing festival and government holiday. Inadequately cleaned and maintained equipment can lead to cross-contamination and variability of drug products.

Must have been a good time. 

Such is the article Warning Letter of the Week: dancing festival edition

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