Inspections, Compliance, Enforcement, and Criminal Investigations
Endogastric Solutions Inc - Response Letter 9/21/10
8210 154th Ave NE
Redmond, WA 98052
September 21, 2010
Mr. Michael J. Donovan
Food and Drug Administration
Seattle Local District Office
22201 23rd Drive SE
Bothell, WA 98021-4421
Re: Warning Letter SEA 10-18
Dear Mr. Donovan,
This letter represents EndoGastric Solution’s (EGS’) response to the two (2) remaining issues discussed in your letter dated July 12 and received by our firm on July 19, 2010. This response is part of EGS’ continuing commitment to comply fully with all applicable FDA laws and regulations. We fully understand our obligations under U.S. Medical Device law and are serious in our intent to continuously improve our business and processes based upon the QSRs and feedback we receive from the FDA.
We appreciate your review of our additional information and given the Agency’s stated position in regards to foreign objects in the esophagus/ stomach, the company has reported the subject complaint investigations as device malfunction MDRs. Reporting these events constituted our corrective action for these two issues. Preventive action included modifying the Company’s standard operating procedure (SOP) in relation to filing MDRs in instances of device malfunctions involving foreign objects in the GI tract.
In addition to the changes described above, the company has also revised its complaint handling procedure to update references to 21 CFR 803- Medical Device Reporting. The procedure now reflects current section references to 21 CFR 803 and the FDA related sections are clearly identified.
This letter also acknowledges FDA acceptance of the corrective action for the third of the original three issues included in the warning letter. Corrective action included removal of a pediatric related video from the company’s website and verification that all other marketing materials contain no references to pediatric use. This is consistent with FDA’s response letter of July 12, 2010.
The Company now considers all issues related to this FDA Warning Letter to be satisfactorily resolved based upon FDA’s response letter received by the company on October 20, 2010, which stated: “After reviewing your letter, it appears you have or intend to take measures to address all of the agency’s concerns outlined in Warning Letter SEA 10-18.” It also further states, “The Company’s corrections will be verified during the next scheduled inspection.”
Finally, we would like to utilize FDA’s policy of posting the company’s response on the FDA Internet website. We therefore request that this letter be posted on that site. Thank you.
Michael A. Daniel
Vice President, Quality Assurance & Regulatory and Clinical Affairs
Cc: Steve Hoffman, Directory Regulatory Affairs and Quality Assurance