Indian manufacturer called out for rust and lackluster records; Spanish CMO signs 10-year commitment to make mRNA vaccines
An India-based Indiana Chem-Port site has been handed a warning letter from the FDA, as the agency came down hard on the drugmaker for cleanliness issues that included rust-like residue on equipment and tape being used to try to prevent contamination.
The lack of cleanliness showed that the company struggled to make APIs that could consistently meet quality standards, the FDA said in the letter dated Feb. 2. It also failed to validate written procedures for the cleaning and maintenance of equipment and failure to establish adequate written procedures.
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