Inspections, Compliance, Enforcement, and Criminal Investigations

Owen Mumford USA, Inc. 6/4/14

  

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

Public Health Service
Food and Drug Administration
 
Atlanta District Office
60 Eighth Street N.E.
Atlanta, GA 30309
Telephone: 404-253-1161
FAX: 404-253-1202

 

June 4, 2014 
VIA UNITED PARCEL SERVICE
 
Mr. Robert E. Shaw
President
Owen Mumford USA, Inc.
1755 W. Oak Commons Street
Marietta, Georgia 30062
 
WARNING LETTER
(14-ATL-08)
 
Dear Mr. Shaw:
 
During an inspection of your firm conducted at 1755 W. Oak Commons Street, Marietta, Georgia, on December 03 – 12, 2013, an investigator from the United States Food and Drug Administration (FDA) determined that your firm is currently packaging and repackaging various medical devices, which include hypodermic needles. 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.
 
Our inspection 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 (MDR). We received a response from you and Ms. Paula Staples, Global Head of Quality, dated December 23, 2014, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, that was issued to your firm.  Significant violations include, but are not limited to, the following:
 
Failure to adequately develop, maintain, and implement written MDR procedures, as required by 21 CFR 803.17. For example, after reviewing your firm’s MDR procedure titled, “MDR Decision/Submission Tree Work Instruction,” Document #OMQA07B.W002, Revision 00, Effective January 30, 2013, the following issues were noted:
 
1.    Doc #OMQA07B.W002, Revision 00, does not establish internal systems that provide for timely and effective identification, communication, and evaluation of events that may be subject to MDR requirements. For example, there are no definitions of what your firm will consider to be a reportable event under 21 CFR Part 803. The exclusion of definitions from 21 CFR 803.3 for the terms “become aware,” “caused or contributed,” “malfunction,” “MDR reportable event,” and “serious injury,” and definitions for the terms “reasonably known” and “reasonably suggests,” found respectively in 21 CFR 803.50(b) and 803.20(c)(1) may lead your firm to make an incorrect reportability decision when evaluating a complaint that may meet the criteria for reporting under 21 CFR 803.50(a).
 
2.    Doc #OMQA07B.W002, Revision 00, does not establish internal systems that provide for a standardized review process to determine when an event meets the criteria for reporting under this part. For example:
 
a.  There are no instructions for conducting a complete investigation of each event and evaluating the cause of the event.
b.  The procedure does not specify who makes the decision for reporting events to FDA.
c.  There are no instructions for how your firm will evaluate information about an event to make MDR reportability determinations in a timely manner.
 
3.    Doc #OMQA07B.W002, Revision 00, does not establish internal systems that provide for timely transmission of complete medical device reports. Specifically, the following are not addressed:
 
a.  The circumstances under which your firm must submit (initial 30 days, supplemental or follow-up, 5 day) reports and the requirements for such reports.
b.  How your firm will submit all information reasonably known to it for each event.
c.  The procedure does not include the address for where to submit MDR reports: FDA, CDRH, Medical Device Reporting, P. O. Box 3002, Rockville, MD 20847-3002.
 
4.    Doc #OMQA07B.W002, Revision 00, does not describe how your firm will address documentation and record-keeping requirements, including:
 
a.  Documentation of adverse event related information maintained as MDR event files.
b.  Information that was evaluated to determine if an event was reportable.
c.  Documentation of the deliberations and decision-making processes used to determine if a device-related death, serious injury, or malfunction was or was not reportable.
d.  Systems that ensure access to information that facilitates timely follow-up and inspection by FDA.
 
Please note: The eMDR Final Rule requiring manufacturers and importers to submit electronic Medical Device Reports (eMDRs) to FDA was published on February 13, 2014.  The requirements of this final rule will take effect on August 14, 2015.  If your firm is not currently submitting reports electronically, we encourage you to visit the following web link for additional information about the electronic reporting requirements:
 
 
If your firm wishes to discuss MDR reportability criteria or to schedule further communications, it may contact the Reportability Review Team by email at ReportabilityReviewTeam@fda.hhs.gov.
 
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.
 
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 (which must address systemic problems) 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 written response should be sent to the U.S. Food and Drug Administration, Attn: Derek Price, Compliance Officer; 60 Eighth Street NE; Atlanta, Georgia 30309. If you have any questions, please contact Mr. Price at 404-253-2277.
 
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,
/S/ 
Ingrid Zambrana
District Director
Atlanta District Office
 
 
CC:
 
Ms. Paula Staples
Global Head of Quality
Owen Mumford USA, Inc.
1755 W. Oak Commons Street
Marietta, Georgia 30062
 

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