Inspections, Compliance, Enforcement, and Criminal Investigations
Sweet Dreems, Inc. 09-Nov-05
Department of Health and Human Services
Public Health Service
Cincinnati District Office
November 9, 2005
VIA FEDERAL EXPRESS
Armondo A. Cuervo
Sweet Dreems, Inc.
4710 E. Walnut Street
Westerville, OH 43081-9609
Dear Mr. Cuervo:
An inspection of your medical device manufacturing firm located in Westerville, OH conducted by our investigator on September 27, 28 and 30, 2005, revealed that your firm manufactures an infant soother, used for the treatment of colic in infants. These are medical devices as defined in section 201(h) of the Federal Food, Drug and Cosmetic Act (the Act) (21 U.S.C. § 321).
Your devices are adulterated within the meaning of section 501(h) of the Act (21 U.S.C. § 351(h)), in that the methods used in, or the facilities or controls used for manufacturing, packing, storage, or installation are not in conformance with the Quality System Regulation (QSR), as specified in Title 21, Code of Federal Regulations (CFR), Part 820. The deviations from the QSR include, but are not limited to, the following:
Corrective and Preventive Actions
1. Failure to record and analyze data regarding in-process and finished production nonconformances and complaints; and failure to establish written corrective and preventive action procedures, as required by 21 CFR 820. 100. For example:
A total of 18 of the 23 complaints, received between 2003 and 2005, pertained to a problem with the vibrating unit on the Sleep Tight Infant Soother. Additionally, the FDA Investigator observed two boxes of approximately 35 defective vibrating units (some returned from customers and some rejected during production). Your firm has not determined the root cause of this problem and no corrective actions have been taken.
2. Failure to review and evaluate complaints; and failure to have written complaint handling procedures, as required by 21 CFR 820.198. For example:
A total of 19 of the 23 complaints do not have documented failure investigations or document why an investigation is not necessary.
Production and Process Controls
3. Failure to have written procedures for the acceptance/rejection of incoming components and finished devices; and failure to document testing activities, as required by 21 CFR 820.80(a) thru (d). For example:
Your firm's receiving acceptance testing for components of the Sleep Tight Infant Soother includes a strobe light test, a visual inspection of the vibrating units, and an audible test on sound generators. This testing is not documented and there are no procedures on how to perform these tests.
Your firm's finished device testing on the Sleep Tight Infant Soother includes an RPM test, visual test, and sound check of the audible generator. This testing is not documented and there are no procedures on how to perform these tests.
4. Failure to establish written standard operating procedures (SOPs) and methods to define and control the production of the Sleep Tight Infant Soothers, as required by 21 CFR 820.70(a).
5. Failure to develop a complete Device Master Record (DMR) for Sleep Tight Infant Soother, as required by 21 CFR 820.181. Specifically, your firm has not developed a DMR that contains or refers to the location of the specifications (i.e. drawings), production process specifications (i.e. manufacturing equipment specifications and production procedures), quality assurance procedures and specifications (i.e. finished device testing criteria), packaging and labeling specifications, and the installation instructions.
6. Failure to maintain device history records for the Sleep Tight Infant Soother; and failure to establish written procedures to assure that the dates of manufacturing, quantity manufactured, all acceptance records and testing, the primary identification label, and any device identification and control number used are documented, as required by 21 CFR 820.184.
7. Failure to perform calibration on testing equipment; and failure to establish a written calibration 9 procedure, as required by 21 CFR 820.72(b). For example, the strobe light tester used to test the vibration motors, which are components of the Sleep Tight Infant Soother, has not been calibrated; and there are no written procedures describing the frequency of calibration and how to calibrate the tester.
8. Failure to evaluate nonconforming product and failure to develop a written procedure to control product that does not conform to specified requirements. This procedure shall address the identification, documentation, evaluation, segregation, and disposition of nonconforming product, as required by 21 CFR 820.90. Specifically, there are two boxes of vibration units, that your firm told the FDA Investigator, were defective. These units are not identified, and their evaluation and disposition are not documented.
9. Failure to establishment the requirements, including quality requirements that must be met by your suppliers, as required by 21 CFR 820.50(a). For example, the suppliers of the sound generator and the vibration unit (the 2 major components of the Sleep Tight Infant Soother) have not been evaluated to determine if each of these suppliers can meet the required specifications.
10. Failure to establish adequate management controls to ensure that an effective quality system has been established and maintained, as required by 21 CFR 820.20. For example:
Quality system procedures have not been established, as required by 21 CFR 820.20(e). For example, there are no written acceptance procedures, production and process control procedures, corrective and preventive action procedures, and design change control procedures.
11. Failure to conduct quality audits ; and failure to develop a written audit procedure to ensure that audits are conducted at sufficient intervals to verify that the quality system is effective in meeting the Quality System Regulation, as required by 21 CFR 820.22.
12. Failure to establish written procedures for the identification, documentation, validation or where appropriate verification, review and approval of design changes before implementation, as required by 21 CFR 820.30(i)
The inspection also revealed that your devices are misbranded under section 502(t)(2) of the Act (21 U.S.C. § 352(t)), in that your firm failed to develop written Medical Device Reporting procedures as required by 21 CFR 803.17.
You should know that these are serious violations of the law. You should take prompt action to correct these deviations. Failure to promptly correct these deviations may result in regulatory action being initiated by the FDA without further notice. Possible actions include, but are not limited to, seizure, injunction, and/or civil penalties.
This letter a is not intended to be an all-inclusive list of deficiencies at your facility. As president of Sweet Dreems, Inc., it is your responsibility to assure adherence to each requirement of the Act and regulations. You are responsible for investigating and determining the causes of the violations identified by the FDA. If the causes are determined to be system problems, you must promptly initiate permanent corrective actions.
Federal agencies are advised of the issuance of all Warning Letters about medical devices so that they may take this information into account when considering the award of contracts. Additionally, no requests for Certifications to Foreign Governments will be approved until the violations related to the subject devices have been corrected.
Please notify this office in writing within fifteen (15) working days of receipt of this letter, of the specific steps you have taken to correct these deficiencies. In addition, please submit any additional documentation to show the corrections initiated in conformance with the requirements of the Quality System Regulation. If corrective action cannot be completed within fifteen (15) working days, state the reason for the delay and the timeframe within which the corrections will be completed.
Your written response to this Warning Letter should be sent to Ms. Gina Brackett, Compliance Officer, Food and Drug Administration, 6751 Steger Drive, Cincinnati, Ohio 45237. If you have any questions concerning the contents of this letter, you may contact Ms. Brackett at (513) 679-2700, extension 167, or you may forward a facsimile to her at (513) 679-2773.
Carol A. Heppe