513.561.1441
More From

Stephanie Love

Haney Successfully Completes FDA Medical Device Assessment

Haney, the Packaging Microfactory, has completed a routine FDA Medical Device Assessment. The audit, facilitated by two FDA medical device inspectors, took place from October 22nd to 24th 2019. This 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 established that Haney’s Cincinnati facility is compliant with the principles and guidelines code of federal regulations for medical device facilities. Closing remarks from investigators indicated no formal observations would be issued.         

“We believe the results of this audit are excellent,” said 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.

Share on facebook
Facebook
Share on twitter
Twitter
Share on linkedin
LinkedIn
Share on email
Email

Other Articles You Might Enjoy

The Future is Flexible Packaging
Package Design

The Future is Flexible Packaging

Flexible packaging is one of the fastest growing segments in the packaging industry. It is defined as any packaging that can readily take the shape of the product inside and combines the best qualities from a variety of different package formats. Flexible packaging provides a multitude of benefits to the Consumer Packaged Goods industry, driving more brands to choose flexible over rigid for their packaging needs.

Subscribe

Send Us A Message

  • This field is for validation purposes and should be left unchanged.