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RyMed receives FDA resolution.
The FDA has found RyMed to be in compliance, after a voluntary recall of product in May 2006. Below are letters issued from RyMed’s Operations Office and from the Food & Drug Agency indicating their case is officially closed.
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From the Office of the Quality Assurance Manager
January 23, 2008
QUALITY ASSURANCE ANNOUNCEMENT
As previously stated, the FDA conducted their follow up inspection of RyMed Technologies, Inc on October 4th, 5th and 9th 2007. No 483 Observations were issued!
RyMed Technologies, Inc. received a FMD-145 dated January 14, 2008 from the Dallas District Office of the FDA stating that the Agency concludes that our inspections (November 2006 and October 2007) are considered closed.
Receipt of this letter from the FDA confirms that the Agency considers all items listed in the Establishment Inspection Reports and the Warning Letter to be corrected to their satisfaction.
Should you have any questions regarding the FMD-145, please feel free to contact me.
Sincerely,
Anna McCutchen
Quality Assurance Manager
6000 W. William Cannon Drive
Building B, Suite 300, Austin, TX 78749
website: www.rymedtech.com
email: amccutchen@rymedtech.com
phone: 512-301-7334
fax: 512-301-7338
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January 14, 2008
Mr. Dana William Ryan, President and CEO
Rymed Technologies, Inc.
137 3rd Avenue North
Franklin, TN 37064
Dear Mr. Ryan:
We are enclosing a copy of the establishment inspection reports (EIR) for the inspections conducted at your premises located at 6000 W. William Cannon Drive, Building B, Suite 300, Austin, Texas 78749 that were concluded on October 9, 2007, and November 8, 2006, by the U.S. Food and Drug Administration (FDA). The Agency concludes that these inspections are considered “closed” under 21 CFR 20.64(d)(3), and will release a copy of the EIRs to the inspected establishment. This new procedure is applicable to EIRs for inspections completed on or after April 1, 1997, For those inspections completed prior to April 1, 1997, a copy of the EIR may still be make available through the Freedom of Information Act (FOIA).
The Agency is working to make its regulatory process and activities more transparent to the regulated industry, Releasing this EIR to you is part of this effort. The copy being provided to you comprises the narrative portion of the report; it reflects redactions made by the Agency in accordance with the FOIA and Title 21, Code of Federal Regulations, Part 20. This, however, does not preclude you from requesting, and possibly obtaining any additional information under FOIA at the following address:
If there is any question about the released information, please feel free to contact Mr. Thao Ta, Compliance Officer, at 214-253-5217.
Sincerely
Elaine Crosby
Acting Dallas District Director
EC:txt
Enclosure(s)
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