Inspections, Compliance, Enforcement, and Criminal Investigations
Potty MD, LLC 23-Aug-07
Department of Health and Human Services
Public Health Service
New Orleans District
Telephone: (615) 366-7801
August 23, 2007
WARNING LETTER NO. 2007-NOL-13
D. Preston Smith, MD
President and Owner
Potty MD, LLC
6512 Baum Drive
Knoxville, Tennessee 37919
Dear Dr. Smith:
During an inspection of your firm, located in Knoxville, Tennessee on June 18-19, 2007, an investigator from the United States Food and Drug Administration (FDA) determined your firm operates as the specifications developer and distributor of enuresis alarm devices. Under Section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), [21 United States Code (USC) 321(h)], these products are devices because they are intended for use in the diagnosis of disease or other condition or in the cure, mitigation, treatment, or prevention of disease, or are intended to affect the structure or function of the body.
This inspection revealed these devices are adulterated within the meaning of Section 501(h) of the Act [21 USC 351(h)], because the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the Current Good Manufacturing Practice (CGMP) requirements of the Quality System regulation found at Title 21, Code of Federal Regulations, Part 820, (21 CFR820). Our investigator's observations were noted on the Form FDA 483, List of Inspectional Observations (FDA 483), issued to Ms. Jennifer Manna, Corporate Director, on June 19, 2007. A photocopy of the Form FDA 483 is enclosed for your review. These violations include, but are not limited to the following:
1. You failed to implement quality system procedures [21 CFR 820.20(e)] prior to the pre-announcement of the inspection on June 11, 2007. No devices should have been manufactured or distributed without a quality system in place.
2. You failed to implement Corrective and Preventive Action (CAPA) procedures before June 15, 2007, even though you have been a specification developer since May 2006 [21 CFR 820.100]. No devices should have been manufactured or distributed without CAPA procedures in place. For example, since June 2006 there have been [redacted] returned devices, and at least [redacted] of these related to a malfunction of your device.
3. You failed to maintain all acceptance records for devices as part of the device history records [21 CFR 820.80(e)]. For example, of the [redacted] lots of Wet-Stop 2 enuresis alarms received by you from the contract manufacturer since March 2006, only [redacted] had acceptance documents forwarded to you for review and approval.
4. You failed to establish written procedures to define and document the review and disposition process for nonconforming product [21 CFR 820.90(b)(1)].
5. You failed to appoint a management representative to ensure quality system requirements are met, and to report to management the performance of the quality system [21 CFR 820.20(b)(3)].
6. You failed to establish, define, document, and implement adequate quality requirements [21 CFR 820.50(a)]. When you acquired the rights to the Wet-Stop 2 enuresis alarms, you changed the contract manufacturer without establishing acceptance criteria for the new manufacturer to meet quality objectives.
7. You failed to establish written procedures to cover the acceptance criteria for the finished enuresis devices [21 CFR 820.80(a)].
The inspection also revealed your devices are misbranded within the meaning of Section 502(t)(2) of the Act, 21 USC 352(t)(2), because your firm failed or refused to furnish material or information respecting the device which is required by or under Section 519 of the Act, 21 USC 360i, and 21 CFR 803 Medical Device Reporting (MDR) regulations. Specifically, you failed to develop, maintain, or implement MDR procedures [21 CFR 803.17], as noted on the FDA 483.
You 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 FDA without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties. Also, Federal agencies are advised of the issuance of all warning letters about devices so they may take this information into account when considering the award of contracts. Additionally, premarket approval applications for Class III devices to which the quality system regulation deviations are reasonably related will not be approved until the violations have been corrected. Requests for Certificates to Foreign Governments will not be granted until the violations related to the subject devices have been corrected.
Please notify this office in writing within fifteen (15) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from recurring. Include documentation of the corrective action you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.
Your response should be sent to Kari L. Batey, U.S. Food and Drug Administration, 404 BNA Drive, Building 200, Suite 500, Nashville, Tennessee 37217. If you have any questions about the content of this letter, please contact Ms. Batey at (615) 366-7808.
This letter is not intended to be an all-inclusive list of the violations at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the FDA 483, issued at the closeout of the inspection, may be symptomatic of serious problems in your firm's manufacturing and quality assurance systems. You should investigate and determine the causes of the violations, and take prompt actions to correct the violations and bring your products into compliance.
H. Tyler Thornburg
New Orleans District
Enclosure: FDA 483