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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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The Judge Rotenberg Educational Center 12/6/12

  

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 

One Montvale Avenue
Stoneham, Massachusetts 02180
(781) 587-7500
FAX: (781) 587-7556

WARNING LETTER
CMS # 367480


VIA UPS Next Day Air

December 6, 2012

Glenda Crookes
Executive Director
The Judge Rotenberg Educational Center
240 Turnpike Street
Canton, Massachusetts 02021-2359
 
Dear Ms. Crookes:
 
On October 3, 2012, through October 17, 2012, an investigator from the United States Food and Drug Administration (FDA) inspected your facility located at 250 Turnpike Street, Canton, Massachusetts.  As a result of this inspection, we observed the Graduated Electronic Decelerators (GED) 3A and GED4 devices at your facility.  Our inspection revealed that your firm has an inventory of (b)(4) GED3A devices and (b)(4) GED4 devices, for a total of (b)(4) GED devices.  Furthermore, our inspection revealed that use of the GED devices has been authorized for (b)(4) students through the Massachusetts Probate Court.

In a letter dated May 23, 2011, FDA notified your facility that the changes and modifications to the originally-cleared GED device require a new premarket notification under 21 CFR 807.81(a)(3).  As a result, the GED3A and GED4 devices violate the Federal Food, Drug, and Cosmetic Act (Act) because your facility has failed to obtain FDA clearance or approval.  Specifically, the devices are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your facility does not have an approved application for premarket approval in effect, pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption under section 520(g) of the Act, 21 U.S.C. § 360j(g). 

In a letter dated June 29, 2012, FDA again notified your facility that the GED3A and GED4 devices are adulterated and require the submission of a premarket notification.  In responses to the letters dated May 23, 2011, and June 29, 2012, your facility stated that it is planning to make a submission under section 510(k) of the Act, 21 U.S.C. § 360(k), for changes and modifications to the GED3A and GED4 devices by December 2012.  We still have not received any submission from your facility.

Your facility should take prompt action to correct the violations addressed in this letter.  Failure to promptly correct these violations may result in regulatory action being initiated by the FDA without further notice.  These actions include, but are not limited to, seizure, injunction, and civil money penalties.  Also, federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information into account when considering the award of contracts.  

Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to correct the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again.  Include documentation of the corrections and/or corrective actions (including any systemic corrective actions) that your firm has taken.  If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities.  If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed.  Your firm’s response should be comprehensive and address all violations included in this Warning Letter.

Your facility’s response to this letter should be sent to:  Karen Archdeacon, Compliance Officer, Food and Drug Administration, One Montvale Avenue, 4th Floor, Stoneham, Massachusetts 02180.  If you have any questions about the content of this letter, please contact Ms. Archdeacon at (781) 587-7491.

In addition, we have scheduled a meeting at the FDA campus in Silver Spring, Maryland, Building 66 on Wednesday, January 9, 2013, to discuss the contents of this letter and to discuss your proposed 510(k) submission.  The purpose of this meeting will be to discuss an appropriate transition period, as of the date of the meeting, to discontinue use of the violative GED3A and GED4 devices.  Use of violative devices after this transition period may subject those devices and responsible persons at your facility to enforcement action, including product seizure, without further notice.  Please contact Ms. Archdeacon, at the above number to confirm this date or to reschedule a mutually convenient time.
 
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your facility.  It is your facility’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. 

Your facility should investigate and determine the causes of the violations noted in this letter, in the Inspectional Observations, Form FDA 483 (FDA 483), issued at the close of the inspection, and in the letters dated May 23, 2011, and June 29, 2012. 

Sincerely yours,

/S/

Mutahar S. Shamsi
District Director
New England District