11.05.19
haneypkg.com has announced it has completed a routine FDA Medical Device Assessment. The audit, facilitated by two FDA medical device inspectors, took place October 22-24, 2019 at the packaging company's Cincinnati, OH, headquarters.
The three-day, on-site, inspection included a detailed facility tour and the review of company policies, employee training, and project documentation. As a producer of small-batch, consumer usable product samples, this procedure establishes that Haney’s Cincinnati facility is compliant with the principles and guidelines code of federal regulations for medical device facilities.
According to Haney, closing remarks from investigators indicated no formal observations would be issued. “We believe the results of this audit are excellent,” says Mike Sewak, Quality Manager at Haney, “This process not only verifies that our quality systems are effective, but provides our clients with the confidence to know that Haney provides commercial product samples that are safe and legal.”
Haney is registered as a repackager/relabeler for 10 medical device listings including both feminine hygiene and dental devices.
The three-day, on-site, inspection included a detailed facility tour and the review of company policies, employee training, and project documentation. As a producer of small-batch, consumer usable product samples, this procedure establishes that Haney’s Cincinnati facility is compliant with the principles and guidelines code of federal regulations for medical device facilities.
According to Haney, closing remarks from investigators indicated no formal observations would be issued. “We believe the results of this audit are excellent,” says Mike Sewak, Quality Manager at Haney, “This process not only verifies that our quality systems are effective, but provides our clients with the confidence to know that Haney provides commercial product samples that are safe and legal.”
Haney is registered as a repackager/relabeler for 10 medical device listings including both feminine hygiene and dental devices.
