‘Late’ 483 Response Triggers Warning to Teco Diagnostics

When Teco Diagnostics was handed a Form 483 with 13 observations in April, it corrected two issues immediately and committed to correcting everything else by June 3. The company sent the FDA a response June 2, explaining how it had corrected the remaining 11 observations. However, the response was sent 25 business days after the close of the inspection, so the FDA refused to consider it before sending a warning letter. In the past, the company has had 30 days to respond to the agency, a spokesman said. Since no regulation or guidance had been issued, the company was unaware that the FDA changed its response policy last September.
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