Safer Sleep, = LLC, Warning Letters

From: Subject: Safer Sleep, LLC, Warning Letters Date: Wed, 4 Jun 2008 16:14:07 -0400 MIME-Version: 1.0 Content-Type: multipart/related; type="text/html"; boundary="----=_NextPart_000_0000_01C8C65E.03AFFDB0" X-MimeOLE: Produced By Microsoft MimeOLE V6.00.2900.3198 This is a multi-part message in MIME format. ------=_NextPart_000_0000_01C8C65E.03AFFDB0 Content-Type: text/html; charset="iso-8859-1" Content-Transfer-Encoding: quoted-printable Content-Location: http://www.fda.gov/foi/warning_letters/s6786c.htm Safer Sleep, = LLC, Warning Letters

FDA Home = Page | Search FDA Site | FDA A-Z Index | Contact FDA

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Department of Health and Human Services

Public Health Service
Food and Drug = Administration

New Orleans District
404 BNA Drive
Building 200 -Suite = 500=20
Nashville, TN 37217

Telephone: (615) 366-7801
FAX: (615) 366-7802=20

May 27, 2008

WARNING LETTER NO. 2008-NOL-10

FEDERAL EXPRESS
DELIVERY SIGNATURE REQUESTED =

Ms. Sue Wright, CEO
Safer Sleep, LLC
3322 West End Avenue, = Suite 705=20
Nashville, Tennessee 37203

Dear Ms. Wright:

During an inspection of your firm, located at 3322 West End Avenue, = Suite=20 705, Nashville, Tennessee on November 13, 16 and 20, 2007, investigators = from=20 the United States Food and Drug Administration (FDA) determined your = firm=20 manufactures the SAFERsleep device. Under Section 201(h) of the Federal = Food,=20 Drug, and Cosmetic Act (the Act), [21 United States Code (USC) 321(h)], = these=20 products are devices because they are intended for use in the diagnosis = of=20 disease or other conditions or in the cure, mitigation, treatment, or = prevention=20 of disease, or are intended to affect the structure or function of the = body.=20

This inspection revealed your devices are adulterated within the = meaning of=20 Section 501(h) of the Act [21 USC 351(h)], because the methods used in, = or the=20 facilities or controls used for, their manufacture, packing, storage, or = installation do not conform with the Current Good Manufacturing Practice = requirements of the Quality System regulation found at Title 21, = Code of=20 Federal Regulations, Part 820 (21 CFR 820). These violations = include, but=20 are not limited to, the following:

l. Failure to establish and maintain procedures for validating the = device=20 design, including software validation, as required by 21 CFR = 820.30(g). For=20 example, your firm provided no documentation of validation of the = embedded=20 software in the SAFERsleep device.

2. Failure to establish and maintain procedures for implementing = corrective=20 and preventive action, as required by 21 CFR 820.100. For example, = although=20 you track issues with the [redacted] you have not = established=20 procedures for corrective and preventive actions or identified the = methods=20 used.

3. Failure to establish and maintain procedures for receiving, = reviewing,=20 and evaluating complaints, as required by 21 CFR 820.198. For example, = although complaints are tracked through your support log and = transcribed into=20 [redacted], you have not established procedures for = reviewing=20 and evaluating complaints, including procedures for determining = whether=20 complaints represent an event which must be reported to FDA under 21 = CFR 803.=20

4. Failure to establish and maintain procedures for acceptance = activities,=20 as required by 21 CFR 820.80. For example, you have not established = procedures=20 for finished device acceptance activities, and you have not = established=20 procedures for acceptance of incoming product, including computers, = keyboards,=20 and bar code scanners. Additionally, you have not established = procedures for=20 receiving and final acceptance of hardware returned from customers = after use.=20

5. Failure to establish and maintain installation and inspection=20 instructions, and test procedures, as required by 21 CFR 820.170(a). = For=20 example, although you claim installation, inspection, and test = procedures have=20 been established, they were not available at the time of inspection = and have=20 not yet been provided.

6. Failure to establish and maintain procedures to ensure all = purchased or=20 otherwise received product and services conform to specified = requirements, as=20 required by 21 CFR 820.50. For example, although you claim to follow = extensive=20 procedures for evaluating potential suppliers, no documentation of = this=20 selection process has been provided.

7. Failure to establish and maintain procedures to control all = documents=20 required by 21 CFR 820, as specified by 21 CFR 820.40. For example, = although=20 you indicate your software [redacted], you have not established = document=20 control procedures for documents [redacted].

8. Failure to establish procedures for quality audits and conduct = such=20 audits to ensure the quality system is in compliance with the = established=20 quality system requirements and to determine the effectiveness of the = quality=20 system, as required by 21 CFR 820.22. For example, you have not = established=20 any procedures for conducting internal quality audits.

9. Failure to establish quality system procedures and instruction, = as=20 required by 21 CFR 820.20. For example:

a. Management with executive responsibility has not appointed a=20 management representative;
b. You have not conducted management = reviews=20 to review the suitability and effectiveness of the quality system; =
c.=20 You have not established a quality plan which defines the quality = practices,=20 resources, and activities relevant to devices which are designed and = manufactured; and,
d. Management with executive responsibility = has not=20 established its policy and objectives for, and commitment to, = quality, and=20 ensured the quality policy is understood, implemented, and = maintained at all=20 levels of the organization.

You presented the investigator with a new, written quality policy = prior to=20 the close of the inspection; however, you have not provided any = documentation=20 the policy has been implemented.

10. Failure to establish = procedures=20 for identifying training needs, and to ensure all personnel are = trained to=20 adequately perform their assigned responsibilities, as required by 21 = CFR=20 820.25. For example, you do not have any training procedures or = documentation=20 identifying training needs.

The inspection also revealed your devices are misbranded under = Section=20 502(t)(2) of the Act,[21 USC 352(t)(2)], because your firm failed or = refused to=20 furnish material or information with respect to the device, as required = by or=20 under Section 519 of the Act [21 USC 360i], and 21 CFR 803 Medical = Device=20 Reporting (MDR) regulation. Significant deviations include, but are not = limited=20 to, the following:

=95 Failure to develop, maintain, and implement written MDR = procedures, as=20 required by 21 CFR 803.17. For example, you were unaware of the MDR = regulation=20 and do not have written MDR procedures.

On December 12, 2007, we received your response dated December 4, = 2007,=20 concerning our investigator's observations noted on the Form FDA 483, = List of=20 Inspectional Observations (483), issued to [redacted] = on=20 November 20, 2007. We reviewed your response and concluded it is = inadequate=20 because it states [redacted] to help formulate a = quality system=20 and promised establishment in early 2008, but you have not provided = evidence of=20 implementation of these corrections.

You should take prompt action to correct the violations addressed in = this=20 letter. Failure to promptly correct these violations may result in = regulatory=20 action being initiated by FDA without further notice. These actions = include, but=20 are not limited to, seizure, injunction, and/or civil money penalties. = Also,=20 Federal agencies are advised of the issuance of all warning letters = about=20 devices so they may take this information into account when considering = the=20 award of contracts. Additionally, premarket approval applications for = Class III=20 devices to which the Quality System regulation deviations are reasonably = related=20 will not be approved until the violations have been corrected. Requests = for=20 Certificates to Foreign Governments will not be granted until the = violations=20 related to the subject devices have been corrected.

Please notify this office in writing within fifteen (15) working days = from=20 the date you receive this letter of the specific steps you have taken to = correct=20 the noted violations, including an explanation of how you plan to = prevent these=20 violations, or similar violation(s), from occurring again. Include = documentation=20 of the corrective action you have taken. If your planned corrections = will occur=20 over time, please include a timetable for implementation of those = corrections.=20 If corrective action cannot be completed within 15 working days, state = the=20 reason for the delay and the time within which the corrections will be=20 completed.

Your response should be sent to: Nicole F. Hardin, Compliance = Officer, U.S.=20 Food and Drug Administration at the above address. If you have any = questions=20 about the content of this letter, please contact Mrs. Hardin at (504) = 219-8818,=20 extension 102 or via fax to (504) 219-8813.

This letter is not intended to be an all-inclusive list of the = violation(s)=20 at your facility. It is your responsibility to ensure compliance with = applicable=20 laws and regulations administered by FDA. The specific violations noted = in this=20 letter and in the 483 issued at the closeout of the inspection may be=20 symptomatic of serious problems in your firm's manufacturing and quality = assurance systems. You should investigate and determine the causes of = the=20 violation(s), and take prompt actions to correct the violations and to = bring=20 your products into compliance.

Sincerely,

/S/

H. Tyler Thornburg
District Director
New Orleans District =

Enclosure: Form FDA 483

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FDA/Freedom=20 of Information

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