Inspections, Compliance, Enforcement, and Criminal Investigations

Gentell 10/5/15

  

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

Public Health Service
Food and Drug Administration
 PHILADELPHIA DISTRICT
900 U.S. Customhouse
2nd and Chestnut Streets
Philadelphia, PA 19106
Telephone: 215-597-4390 

 

WARNING LETTER
15-PHI-21
 
 
Delivered Via United Parcel Service
 
 
October 05, 2015
 
Mr. Frederic Brotz, President
Gentell Inc.
2701 Bartram Road
Bristol, PA 19007-6810
 
Dear Mr. Brotz:
 
During an inspection of your firm located in Bristol, Pennsylvania, on July 29, 2015 through August 25, 2015, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures various wound dressings and gauzes.  Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), your wound dressings and gauzes 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 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, their manufacture, packing, storage, or installation are not in conformance with the current  Good Manufacturing Practice (cGMP) requirements for medical devices which are set forth in the Quality System (QS) regulation, as specified in Title 21, Code of Federal Regulations (CFR), Part 820.
 
We received your firm’s response, dated September 15, 2015, concerning our investigator’s observations noted on the Form FDA 483, Inspectional Observations Report that was issued to your firm on August 25, 2015.  We have addressed your responses below in relation to each of the noted violations.  These violations include, but are not limited to the following:
 
1.    Failure to adequately establish and maintain an organizational structure to produce devices in accordance with 21 CFR 820.20
 
Your firm has not sufficiently demonstrated that appropriate personnel with the necessary education and training are given the authority to assess the quality of medical devices (e.g., gauze, gel and wound dressings) made and/or distributed by your facility.  
 
For example, the current structure of your firm does not identify an organizational unit and/or management representatives who have the authority over and responsibility for ensuring that quality system requirements are actively established and achieved, and  maintained, reviewed, audited and adhered to, and that any deviations/deficiencies are reported to management with executive responsibility to effect product compliance with the Quality System regulation through a management review process. 
 
This was substantiated during the inspection, when your firm representative, responding to the investigator’s inquiries about whether the firm had a quality system with oversight over the manufacturing of medical devices (i.e. gauzes, gel and wound dressings), replied that he was not aware of a quality system, and that he was not familiar with the regulations applicable to medical devices.  It was also explained that some of the records and SOPs provided to the investigator during the inspection are not applicable to Gentell organization.  Additionally, it was stated that the firm’s management has not established a management representative with oversight over medical device quality.  And, that manufacturing reviews are not performed, and there are no written procedures on how to conduct management reviews.  Furthermore, it was stated that quality audits are not performed by the firm, and have not been conducted since 2007, that nobody is trained regarding FDA’s requirements for manufacturing medical devices, and that the firm has not been audited by any outside companies, nor have they hired an outside contractor.
 
Your firm response of 9/15/2015, headed as Meeting to revise and finalize FDA - report from 07/29/2015 to 08/25/2015 and information to accompany the report, stated the following: “Management of Gentell, Inc. is now aware of their responsibility to assign management representatives with their responsibilities in order to make the quality system work.” Also, your firm has assigned the (b)(4) person to oversee the quality system requirements, maintain and report on the performance of the quality system.  It was stated, “This requirement will be reflected in the written procedure with management responsibility under Quality System Requirements. The working Organizational Chart is attached.  A list of duties for each person responsible for the quality system is being compiled by for the quality system implementation and control.”
 
Your firm response stated, “Gentell, Inc. is now aware of the management review process and key role it plays in the success of the quality system as per their audit by third party.  An annual review meeting of the entire quality system which includes complaints, corrective and preventive actions will be put in place and reflected in the written procedure with management responsibility under Quality System Requirements”
 
Your firm response further stated, “Gentell, Inc. is now aware of the responsibility of the Quality Control person to perform Internal Audits on a scheduled basis and is implementing quarterly audits of the quality system that will be reflected in the written procedure under Quality System Requirements”
 
However, your submitted written response shows that as top firm official, you did not sign off on these proposed changes; and that the corrective actions proposed lack a specific timeframe for their completion, and that there was no objective documentation provided for our review to verify that the proposed changes were implemented.  Further, the adequacy of your responses can only truly be evaluated and verified during the next scheduled inspection.
 
2.    Failure to establish procedures for corrective and preventive action, as required by 21 CFR 820.100(a)
 
Your firm’s management has not analyzed the development, manufacturing, storage, and distribution of their medical devices to identify sources of quality data to identify quality problems.  Procedures have not been established to identify, investigate, and correct/prevent quality problems.
 
Specifically, SOPs were provided during the inspection, but there was no SOP that addressed an established CAPA system included in the records.
                       
Your firm’s response of 9/15/2015 states, “After being audited by third party auditor, Gentell's management realizes the importance of "Corrective and Preventive Action".  While they have a basic complaint system in place there is no process to evaluate or follow up on corrective and preventive action procedures at this time; however, it will be implemented immediately and be reflected in the written procedure, Corrective and Preventive Action”
 
However, your submitted response shows that as top firm official, you did not sign off on these proposed changes; and there was no objective documentation provided for our review to verify the proposed changes.
 
We acknowledge your response to bring the firm into compliance; however, the adequacy of your response can only truly be evaluated and verified during our next scheduled inspection.
 
3.    Failure to establish a formally designated unit and procedures for receiving, reviewing, and evaluating complaints, as required by 21 CFR 820.198(a)
 
Your firm’s management  has not established a documented process for receiving, evaluating, investigating (as necessary) product complaints resulting from the possible failure of the device; specifically a lack of essential elements required to evaluate and or escalate complaints that may be reportable as adverse events.
 
We acknowledge your response to bring the firm into compliance; however, the adequacy of your response can only truly be evaluated and verified during our next scheduled inspection.
 
4.    Processes whose results cannot be fully verified by subsequent inspection and test has not been validated according to established procedures, as required by 21 CFR 820.75(a)
 
a.    The manufacturing process for (b)(4) tubes has not been validated to assure the process consistently produces a finished product meeting established predetermined specifications. For example, there is no specification for the quantity of silver in the finished product.  In addition, process controls for the addition of raw materials, mixing times and temperature have not been established. 
 
b.    There is no evidence the gamma sterilization process for (b)(4) dressings has been validated.  
 
c.    Package sealing for (b)(4), has not been validated to assure process control parameters will produce an acceptable seal.
 
We acknowledge your response to bring the firm into compliance; however, the adequacy of your response can only truly be evaluated and verified during our next scheduled inspection.
 
5.    Failure to maintain a device master record, as required by 21 CFR 820.181
 
You firm management  has not established an approved device master record (DMR) for the manufacturing of (b)(4) Wound Dressings.  Furthermore, there is no evidence of approved specifications for equipment, production methods, components, production environment, formulations, packaging and labeling.
 
We acknowledge your response to bring the firm into compliance; however, the adequacy of your response can only truly be evaluated and verified during our next scheduled inspection.
 
6.    Failure to maintain a device history record, as required by 21 CFR 820.184
 
Numerous device history records (DHR), Lot Numbers: (b)(4) tubes, do not contain records that verify the device was manufactured in accordance with an approved device master record. The DHR does not include the label and/or labeling used nor are there written procedures for the examination and release of device labeling. Additionally, there are no written procedures describing device history records.
 
We acknowledge your response to bring the firm into compliance; however, the adequacy of your response can only truly be evaluated and verified during our next scheduled inspection.
 
7.    Failure to evaluate and train employees to perform the necessary tasks of a medical device manufacturer, as required by 21 CFR 820.25(a)
 
Employees of your firm who are responsible for the development, manufacture, storage and distribution of medical devices are not trained with respect to established quality objectives related to the performance of their jobs. Further, written operating procedures that coincide with the requirements of the current Good Manufacturing Procedures have not been established to ensure employees are properly educated to perform their jobs.
 
We acknowledge your response to bring the firm into compliance; however, the adequacy of your response can only truly be evaluated and verified during our next scheduled inspection.
 
8.    Additionally, please clarify the term “NDC#” and the rationale for its use on your various device product labels.
 
Finally, while we do recognize your attempts to achieve voluntary compliance, your corrective actions cannot be fully evaluated until you are able to demonstrate to the FDA, through subsequent reports with objective documentation, and during our next inspection, that the corrective actions have been implemented and followed, and are sufficient to maintain the firm in a state of control with respect to the Quality System regulation.
 
Your firm should take prompt action to correct the violations addressed in this letter.  Failure to correct these violations promptly 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 consider this information 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. 
 
Please notify this office in writing within fifteen (15) 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 (15) 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 written response should be sent to Joseph A. Morkunas, Compliance Officer, U.S. Food and Drug Administration, 900 U.S. Customhouse, 200 Chestnut Street, Philadelphia, Pennsylvania 19106. If you have any questions about this letter, please contact Mr. Morkunas at (215) 717-3079 or e-mail at Joseph.Morkunas@fda.hhs.gov.
 
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/ 
Anne E. Johnson
Acting District Director
Philadelphia District
 
 
cc:        Pennsylvania State Department of Health
            132 Kline Plaza, Suite A Harrisburg, PA 17104
            Attention: Director, Division of Primary Care and Home Health Services

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