The QMN Weekly Bulletin

Numerous Procedural Violations Leads To Form 483 for Hoggan Scientific

Dec. 16, 2016

Hoggan Scientific LLC has been hit with a Form 483 after an inspection revealed a lack of adequate procedures for design control, corrective and preventive actions, complaint evaluation, and other issues.

Hoggan’s Salt Lake City, Utah, facility was inspected in January and investigators discovered the manufacturer of diagnostic and measurement products failed to maintain several design control elements for its microFET 2 dynamometer; including a design development plan; inputs and outputs; review; verification and validation; and transfer.

Investigators also pointed out that Hoggan had not established procedures for analyzing quality data, investigating the cause of product nonconformities; and identifying; verifying; and implementing corrective and preventive actions.

Other observations include a lack of written procedures, device master record and procedures for quality audits that have not been maintained

In total 13 observations were mentioned in the letter.

Everyone breathes a sigh of relief when the FDA investigators depart. But if they left behind a Form 483 pointing out deficiencies and noncompliances, that’s when the work really starts. The good news is that a well-reasoned response can help a company side step a warning letter or worse. The bad news is that the agency gives you only 15 business days to pull it together. Order your copy of Effective 483 Responses: Focus on CAPA Violations to correct and prevent these issues.

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