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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Ogenix Corporation 3/27/12


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 


March 27, 2012                                              
WARNING LETTER                                                                      VIA UPS
Srinivasan Sarangapani, Ph.D.
Ogenix Corporation
588 Pleasant Street, Unit 2
Norwood, MA 02062
Dear Mr. Sarangapani:
During an inspection of your firm located in Beachwood, Ohio on February 13 through March 1, 2012, an investigator from the United States Food and Drug Administration (FDA) determined that your firm is a specification developer for a topical oxygen system called the EpiFLO. 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 are intended to affect the structure or 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 manufacturing, 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 (C.F.R.), Part 820. 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.      You have not implemented your “Supplier Management Procedure”, which requires that your critical suppliers (Classification A) receive an initial assessment to include completion of a supplier assessment form, on-site or 3rd party assessment, or documentation of exemption. Additionally, the annual review of the Classification A suppliers is not being performed.
b.      The critical supplier of your membrane electrode assembly is not on the approved supplier list. 
2.    Failure to validate the new EpiFLO design to ensure that devices conform to defined user/patient needs and intended uses, as required by 21 C.F.R. § 820.30(g). Specifically,
Design validation was not performed on the new EPIFLO – 7 Day and EpiFLO -15 Day devices released in August of 2006. Your “Design and Development Plan for Ogenix EpiFLO Unit”, Rev. 2, dated 8//7/06, section 12 states that a “Verification/Validation Plan will be generated and maintained by Ogenix”. This has not been done.
3.    Failure to adequately establish design inputs that ensure that the design requirements relating to a device are appropriate and address the intended use of the device, including the needs of the user and patient, as required by 21 C.F.R. § 820.30(c). Specifically,
The “Product Specification – 7 Day EpiFLO” and “Product Specification –15 Day EpiFLO” documents, dated 4/26/06, do not include a requirement for strength and durability. These devices are worn 24/7 during normal daily activity and while sleeping. Additionally, your firm has opened five corrective and preventive actions to address the issue of complaints do to the luer lock breaking.
4.    Failure to establish a complete risk analysis, as required by 21 C.F.R. § 820.30(g).
Specifically, your current risk analysis for the EpiFLO devices, FMEA dated December 2, 2008, does not include risks concerning strength and durability, which were  reported from field complaints involving breakage of the luer locks. Your risk analysis has not been updated to include this potential risk.
5.    Failure to establish and maintain procedures for the validation or where appropriate verification of design changes before their implementation, as required by 21 C.F.R. § 820.30(i).  
a.      The verification testing performed on the design change to the luer lock, “Ogenix EPIFLO Luer Stem Shear Test”, dated 9/29/11, is inadequate in that it does not include established acceptance criteria for the strength of the luer lock to prevent breakage.
b.      Validation testing was not performed to ensure that the new design conforms to defined user needs and intended uses.
6.    Failure to establish and maintain corrective and preventive action procedures that include requirements for ensuring the corrective and preventive action is effective, as required by 21 C.F.R. § 820.100(a)(4). For example,
You are not following your “Corrective and Preventive Action” procedure, QS001-SP, Rev E, dated 12/10/08, section 8.0 “Flow Chart” which states “QA follow-up verification: was solution effective?”. A total of 8 of the 15 corrective and preventive actions (CPANs) reviewed did not document the effectiveness of the actions taken.    
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 that they may take this information into account when considering the award of contracts. Additionally, no premarket submission to which the Quality System regulation deficiencies are reasonably related will 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 as to 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 occurring again. Include documentation of the corrective actions 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, please state the reason for the delay and the time within which the corrections will be completed.
Your written response 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, ext. 2167, or you may forward a facsimile to her at (513) 679-2773.
Finally, you should know that this letter is not intended to be an all-inclusive list of violations at your firm. 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 Inspectional Observations, Form 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 to bring your products into compliance.
Paul J. Teitell
District Director
Cincinnati District