• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

  • Print
  • Share
  • E-mail

The Utopia Group LLC 5/21/14

  

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

Public Health Service
Food and Drug Administration
 
Cincinnati District Office
Central Region
6751 Steger Drive
Cincinnati, OH 45237-3097
Telephone: (513) 679-2700
             FAX: (513) 679-2771 

 

May 21, 2014                                     
 
 
WARNING LETTER                                                                     
CIN-14-430102-13
 
VIA UPS
 
Mark W. Bode, CEO
The Utopia Group, LLC
6279 Tri Ridge Blvd., Suite 207
Loveland, OH 45140
 
Dear Mr. Bode:
 
During an inspection of your firm located in Loveland, OH on March 17 through 27, 2014, an investigator from the United States Food and Drug Administration (FDA) determined that your firm is the specification developer of an Joey Spray Guard umbilical cord clamp and cutter.  Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body.
 
This inspection revealed that these 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, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820.  We received a response from you, dated April 16, 2014, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations that was issued to your firm. We address this response below, in relation to each of the noted violations. These violations include, but are not limited to, the following:
 
1. Failure to establish and maintain procedures to ensure that all purchased or otherwise received products and services conform to specified requirements, as required by 21 C.F.R. § 820.50. Specifically,
 
a)      Your “Supplier Qualification Procedure”, not dated, does not address evaluating and selecting potential suppliers, contractors and consultants on the basis of their ability to meet specified requirements, including quality requirements; and does not define the type and extent of control to be exercised over the product, services suppliers, contractors, and consultants.   For example, the requirements, including quality requirements, the contract manufacturer of the umbilical cord clamp and cutter must meet have not been established.
b)      All suppliers, contractors and consultants have not been evaluated on the basis of their ability to meet specified requirements, including quality requirements. For example, the process validation and the ability of your contract manufacturer of the umbilical cord clamp and cutter to meet specifications were not evaluated.  
c)      There is no established list of acceptable suppliers, contractors, and consultants.
 
The adequacy of your firm’s response cannot be determined at this time. Your response states you have initiated Corrective Action #CAPA 14-001 to document the investigation, corrective & preventive actions and verification of effectiveness of this observation. Please provide an update of this corrective action. If the timeframes discussed in your response cannot be met, please include the new timeframes.  
 
2. Failure to establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met and demonstrate that the design was developed in accordance with the design control requirements, as required by 21 C.F.R. § 820.30. Specifically,
 
a)       Your “Design Review Board” procedure and “Testing Procedure”, both not dated, do not address design and development planning, design inputs, design outputs, design review, design verification, design validation, risk analysis, design transfer, and design history file.
 
b)       Design inputs, design outputs, design verification, design validation, design reviews, and design transfer have not been established for the Joey Spray Guard umbilical cord clamp and cutter.
 
The adequacy of your firm’s response cannot be determined at this time. Your response states you have initiated Corrective Action #CAPA 14-002 to document the investigation, corrective & preventive actions and verification of effectiveness of this observation. You also state that you will retrospectively prepare the design control documents for the umbilical cord clamp and cutter. Please provide an update of this corrective action. If the timeframes discussed in your response cannot be met, please include the new timeframes. 
           
3. Failure to establish and maintain procedures for implementing corrective and preventive actions, and document all activities required under this section, as required by 21 C.F.R. § 820.100(a) and (b). Specifically,
 
a)       There are no written procedures addressing analyzing processes, work operations, concessions, quality audit reports, quality records, service records, complaints, returned product, and other sources of quality data to identify existing and potential causes of nonconforming product, or other quality problems; investigating the cause of nonconformities; identifying the actions needed to correct and prevent recurrence of nonconforming product and other quality problems; verifying or validating corrective and preventive actions; implementing and recording changes in methods and procedures; ensuring that information is disseminated to those directly responsible for the quality of the product; and submitting relevant information for management review.
 
b)       The March of 2014 evaluation, investigation, and changes being made to the Joey Spring Guard Clamp, do to complaints of infant clamp slippage on the umbilical cord and the infant clamp falling off, are not being completed in accordance with the requirements of 21 C.F.R. § 820.100.
 
The adequacy of your firm’s response cannot be determined at this time. Your response states you have initiated Corrective Action #CAPA 14-004 to document the investigation, corrective & preventive actions and verification of effectiveness of this observation. Corrective Action #CAPA 14-011 has been initiated to document the investigation, corrective actions, and verification of effectiveness for changes to the clamp’s mold. Please provide an update of this corrective action. If the timeframes discussed in your response cannot be met, please include the new timeframes. 
 
4. Failure to establish and maintain procedures to control product that does not conform to specified requirements, as required by 21 C.F.R. § 820.90(a). Specifically,
 
There are no written procedures addressing the evaluation and investigation of non-conformances; and the testing performed during investigations is not being documented. For example, on 5/14/2013, your contract manufacturer opened a nonconformance report (NCR#:13-012) stating “Dimensional data of single cavity cutter (Tool# J-294) does not meet print.” The testing by your firm of the non-conforming product on “fresh placenta cords of varying sizes”, discussed in your investigation report, was not documented.
 
The adequacy of your firm’s response cannot be determined at this time. Your response states you have initiated Corrective Action #CAPA 14-003 to document the investigation, corrective & preventive actions and verification of effectiveness of this observation. You will also review all NCRs to verify evaluations, dispositions, and corrections have been appropriately documented. Please provide an update of this corrective action. If the timeframes discussed in your response cannot be met, please include the new timeframes. 
 
5. Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 C.F.R. § 820.198(a). Specifically,
 
Your “Customer/User Report/Complaint Procedure”, not dated, is not adequate. The 5 complaints received by your firm did not document the date the complaint was received, device identification number, reply to complainant, and the review of the complaint to determine if it represents an event which must be reported to FDA under part 803, Medical Device Reporting.
 
The adequacy of your firm’s response cannot be determined at this time. Your response states you have initiated Corrective Action #CAPA 14-006 to document the investigation, corrective & preventive actions and verification of effectiveness of this observation. You will also reevaluate all 5 complaints received. Please provide an update of this corrective action. If the timeframes discussed in your response cannot be met, please include the new timeframes.  
 
6. Failure to establish and maintain procedures to control all documents that are required by 21 C.F.R Part 820, as required by 21 C.F.R. § 820.40. Specifically,
 
There are no written document control procedures. All quality system procedures have not been signed and dated by an individual who has been designated to review the procedures for adequacy and approval prior to issuance.
 
The adequacy of your firm’s response cannot be determined at this time. Your response states you have initiated Corrective Action #CAPA 14-009 to document the investigation, corrective & preventive actions and verification of effectiveness of this observation. Please provide an update of this corrective action. If the timeframes discussed in your response cannot be met, please include the new timeframes. 
 
7. Failure to establish procedures for quality audits and to conduct such audits to assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system, as required by 21 C.F.R. § 820.22.
 
The adequacy of your firm’s response cannot be determined at this time. Your response states you have initiated Corrective Action #CAPA 14-007 to document the investigation, corrective & preventive actions and verification of effectiveness of this observation. Your response also states that a third party will conduct your quality audit. Please provide an update of this corrective action. If the timeframes discussed in your response cannot be met, please include the new timeframes. 
 
8. Failure to establish procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities, as required by 21 C.F.R. § 820.25(b).
 
The adequacy of your firm’s response cannot be determined at this time. Your response states you have initiated Corrective Action #CAPA 14-008 to document the investigation, corrective & preventive actions and verification of effectiveness of this observation. Your response also included a copy of your “Training” procedure, SOP 62-01, dated 4/16/14. We will determine the adequacy of the implementation of this procedure during a future inspection. Please provide an update of this corrective action. If the timeframes discussed in your response cannot be met, please include the new timeframes. 
 
9. Failure of management with executive responsibility to ensure that an effective quality system has been established and implemented, as required by 21 C.F.R. § 820.20. For example,
 
a)      A quality policy has not been established.
b)      A management representative has not been appointed.
c)      Formal management review meetings, which review the suitability and effectiveness of the quality system, have not been conducted.
d)     A quality plan has not been established.
 
The adequacy of your firm’s response cannot be determined at this time. Your response states you have initiated Corrective Action #CAPA 14-010 to document the investigation, corrective & preventive actions and verification of effectiveness of this observation. Your response also provides documentation of the appointed management representative. Please provide an update of this corrective action. If the timeframes discussed in your response cannot be met, please include the new timeframes. 
 
Our inspection also revealed that your firm’s devices are misbranded under section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), in that your firm failed or refused to furnish material or information respecting the device that is required by or under section 519 of the Act, 21 U.S.C. § 360i, and 21 CFR Part 803 - Medical Device Reporting.  Significant violations include, but are not limited to, the following:
 
Failure to develop written medical device reporting (MDR) procedures as required by 21 C.F.R. § 803.17.
 
The adequacy of your firm’s response cannot be determined at this time. Your response states you have initiated Corrective Action #CAPA 14-005 to document the investigation, corrective & preventive actions and verification of effectiveness of this observation. Please provide an update of this corrective action. If the timeframes discussed in your response cannot be met, please include the new timeframes. 
 
Your firm 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. Additionally, premarket approval applications for Class III devices to which the Quality System regulation violations 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 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 firm’s response should be sent to: 6751 Steger Drive, Cincinnati, OH 45237. Refer to CIN-14- 430102-13, when replying. If you have any questions about the contents of this letter, please contact: Gina M. Brackett, Compliance Officer at (513) 679-2700, extension 2167 or fax at (513) 679-2775.
 
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility.  It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA.  The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems.  Your firm should investigate and determine the causes of the violations, and take prompt actions to correct the violations and bring the products into compliance. 
 
 
Sincerely yours,
 /S/                                                       
 Paul J. Teitell
 District Director
Cincinnati District Office