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Hammill Manufacturing Completes Recent FDA Inspection
2nd successful audit in the last three years.
Maumee, OH January 25, 2013: ...
Maumee, OH January 25, 2013: Hammill Manufacturing Company announced today that on December 7, 2012, they received an Establishment Inspection Report (EIR) from the FDA (US Food and Drug Administration) which confirmed the results of their latest FDA Inspection - no observations were noted, and no FDA 483 Inspectional Observations were issued. This was Hammill’s second successful Quality Audit with the FDA in the last three years.
Back in 2008, the FDA issued a warning letter to Hammill outlining several observations relating to document traceability and control as well as, following CAPA procedures consistently. “The warning letter did not involve any Customer product; however, the findings showed that our Quality Systems were not up to par and that procedures were not consistently being followed. This was unacceptable to the FDA and frankly unacceptable to our company philosophy,” noted John Hammill, President.
Hammill Medical took the necessary steps to review, evaluate, and improve their quality system. “The renewed emphasis on quality systems and controls has paid off for our company and for our customers. The recent FDA investigation was conducted over an eight day period. We are excited that our quality systems continue to improve. The most recent investigation highlights the progress we have made . . . no observations noted and no FDA 483 Observations issued”, expressed John Hammill.
Headquartered in Maumee, OH (near Toledo), Hammill Manufacturing Company has been in business for 58 years and is a world class contract medical device manufacturer focused on Orthopedic Implant Systems, Spinal Implant Systems, Surgical Instruments, Prototype Manufacturing and Product Development. Hammill Medical operates within the Good Manufacturing Practices guidelines, and the manufacturing facility is ISO 13485 certified. In addition Hammill is registered as a contract manufacturer of implantable medical devices by the Food and Drug Administration [FDA # 1530390].
We also want to announce our new company logo (shown above). This logo reflects the 58 year history using the traditional font of the Hammill name with the new energetic, dynamic green dot design showing the Hammill “H” and our ability to “Connect the Dots” to help our customers achieve their product success through manufacturing excellence.
Contact: Stan Pearson
Division of Hammill Manufacturing Company
Phone: (419) 476-0789
Fax: (419) 476-7568
360 Tomahawk Dr.
Maumee, OH 43537