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U.S. Department of Health and Human Services

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Enforcement Actions

Ontex Hygieneneartikel Gmbh 8/1/13

  

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

Public Health Service
Food and Drug Administration
 10903 New Hampshire Avenue
Silver Spring, MD 20993 

 

August 1, 2013
 
WARNING LETTER
 
 
VIA UNITED PARCEL SERVICE
 
Jurgen Preusche
Managing Director
Ontex Hygieneneartikel Gmbh
30, Fabrikstrasse
Grospostwitz, Germany
 
Dear Mr. Preusche:
 
During an inspection of your firm located in Grospostiwitz, Germany, on April 8 through April 11, 2013, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures tampons and applicators.  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 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 Ms. Katrin Ringel, Quality Manager, dated April 29, 2013, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, which 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 ensure that, when the results of a process cannot be fully verified by subsequent inspection and test, the process shall be validated with a high degree of assurance and approved according to established procedure, as required by 21 CFR 820.75(a). For example,
    1. Your firm does not have written validation procedures for the tampon manufacturing process. Your firm’s tampon production parameters (e.g., (b)(4)) are being implemented based on historical knowledge. Your firm does not have formal documentation of acceptance criteria available to assure production of acceptable products.  
 
    1. During the inspection, your firm’s production line DR17 for digital 100% organic tampons revealed out-of-trend production yields. Your firm attributed this result to equipment maintenance. However, your firm failed to take additional measures to bring the tampon production process into a state of control. 
 
    1. Your firm failed to document equipment operating parameters during the validation run for the (b)(4) project (b)(4).
           
We reviewed your firm’s response and conclude that it is not adequate. The response indicated that your firm plans to categorize machine types and gather operating parameters for each machine type by May 2013.  However, your firm’s response did not address the requirement for establishing a tampon validation procedure and validation of the tampon manufacturing process per the new procedure. Additionally, your firm’s response failed to address whether other processes will be evaluated for similar deficiencies. As of July 22, 2013, FDA has not received evidence of implementation of your firm’s corrective action.  
 
2.    Failure to establish and maintain procedures for monitoring and control of process parameters for validated processes to ensure that the specified requirements continue to be met, as required by 21 CFR 820.75(b). For example, your firm has (b)(4) tampon production lines running at various speeds. Your firm has not qualified the production parameters (e.g., (b)(4)). These parameters are being implemented based on historical knowledge. Additionally, your firm does not have documentation of acceptable production parameters to assure that the specified requirements are met.   
 
The adequacy of your firm’s response cannot be determined at this time. The response indicated that your firm plans to categorize machine types and gather operating parameters for each machine type by May 2013. However, your firm’s response did not address whether other processes and procedures will be evaluated for similar deficiencies.  As of July 22, 2013, FDA has not received evidence of implementation of your firm’s corrective action.  
 
3.    Failure to establish and maintain adequate procedures to control the design of the device in order to ensure that specified requirements are met, as required by 21 CFR 820.30(a). For example:
 
a.    Your firm’s design plan for the (b)(4) project, dated April 9, 2013, does not address how design and development activities will be implemented.
 
b.    During the inspection, your firm’s personnel explained to the FDA investigator that the (b)(4) project conducted testing on (b)(4) on a (b)(4) basis; however, the study results were not documented.
 
c.    Your firm has not established design input for the (b)(4) project involving newly designed (b)(4)
 
d.    At the time of the inspection, the FDA investigator was given a design review document that did not include the date and names of the individual participants in the design reviews.
 
e.    Your firm’s Design History File for synthetic tampons failed to reference and document information related to design input and output specifications.
 
We reviewed your firm’s response and conclude that it is not adequate. The response indicated that your firm plans to update its system and procedures for new product development by June 2013. However, your firm’s response failed to address how the missing information for the (b)(4) project will be recovered. Additionally, your firm’s response failed to address whether design files for all design projects and currently marketed devices will be retrospectively reviewed for similar deficiencies. As of July 22, 2013, FDA has not received the revised procedures and updates that have been made to the design control system for review.
 
4.    Failure to establish and maintain procedures for rework, to include retesting and reevaluation of nonconforming product after rework, to ensure that the product meets its current approved specification, as required by 21 CFR 820.90(b)(2). For example, your firm conducts rework routinely and the reworked products are distributed to your customers. However, your firm has not established rework procedures. Additionally, a review of your firm’s nonconformance log book indicated that the rework details, including the reason for rework, the QA review, the task and the device history record addition were incomplete. 
 
The adequacy of your firm’s response cannot be determined at this time. The response indicated that your firm plans to establish a rework procedure by May 2013. However, as of July 22, 2013, FDA has not received the rework procedure for review.
 
5.    Failure to maintain complaint files and establish and maintain adequate procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a). For example: 
 
a.    Your firm’s Compliant Handling Procedures; Customer and Consumer Complaints Handling Process GPP-QUA-03, Revision 05, dated April 12, 2012, and Incident Management Procedure GPP-QUA-07, Revision 1, dated January 12, 2010, did not address how complaints associated with adverse events are communicated to the corporate office for medical device reporting (MDR) determination. Specifically, your firm received complaints related to (b)(4) (complaint #57497) and (b)(4) (complaint # 60997). These complaints are considered emergency complaints that should trigger a separate e-mail to the firm’s Quality Manager and Group Quality Manager per GPP-QUA-03. However, your firm’s procedure does not provide instructions for how the Quality Managers will further process and communicate possible MDR reportable events to the corporate office.
 
b.    Your firm received (b)(4) complaints from (b)(4) noting problems with the (b)(4). Your firm also received complaints from (b)(4) for (b)(4) and (b)(4) issues. However, your firm’s Incident Management Procedure GPP-QUA-07 does not indicate how root cause investigations are conducted for product complaints, nor does it allow for evaluation of product complaints related to potential adverse events.  
 
c.    Your firm’s Compliant Handling Procedure GPP-QUA-03 indicates that complaint investigations should be available at least 14 days after a complaint has been entered into the complaint database. However, your firm did not have the investigations available within the 14-day time period for several complaints. Examples of these complaints include:
 
i.    Complaint # 61233 involving (b)(4)
ii.    Complaint # 57751 involving (b)(4)
iii.    Complaint # 62165 involving (b)(4)
iv.    Complaint # 58379 involving (b)(4)
v.    Complaint # 56999 involving (b)(4)
vi.    Complaint # 48838 involving (b)(4)
 
The adequacy of your firm’s response cannot be determined at this time. The response indicated that your firm plans to update its system and procedures on a group level and also locally by June 2013. However, your firm’s response did not address whether complaint files will be retrospectively reviewed for MDR reportable events. Additionally, as of July 22, 2013, FDA has not received the revised procedures, evidence of corrective actions from the retrospective review of MDRs, and a summary of updates to the complaint handling system for review.
 
6.    Failure to review, evaluate, and investigate complaints involving the possible failure of a device, labeling, or packaging to meet any of its specifications unless such investigation has already been performed for a similar complaint and another investigation is not necessary, as required by 21 CFR 820.198(c). For example, during the inspection, the FDA investigator reviewed complaints 55877 and 62165, involving (b)(4). However, your firm did not have an evaluation and investigation available for these complaints.       
 
We reviewed your firm’s response and conclude that it is not adequate. The response indicated that your firm plans to update its system and procedures on a group level and also locally by June 2013. However, your firm’s response failed to address whether complaints involving possible device failure will be retrospectively reviewed per the revised procedure. Additionally, as of July 22, 2013, FDA has not received the revised procedures, evidence of corrective actions from the retrospective review of the complaint files, and a summary providing updates to the complaint handling system for review.
 
7.    Failure to establish and maintain procedures to ensure that sampling methods are adequate for their intended use and to ensure that when changes occur the sampling plans are reviewed, as required by 21 CFR 820.250(b). For example, your firm’s sampling plans for in-process and finished tampons are not based on a valid statistical rationale. Specifically,
 
a.    Your firm’s current practice is to evaluate (b)(4) samples for (b)(4), (b)(4) samples for (b)(4), and (b)(4) samples for (b)(4) testing for (b)(4) tampons. Your firm’s average lot size for tampon production is (b)(4) tampons.  However, your firm has not established finished device sampling plans based on a valid statistical rationale.
 
b.    Your firm’s practice is to test (b)(4) in-process tampons (b)(4) from a production line. The production line yield may vary depending on the line speed and equipment used. However, your firm has not established in-process sampling plans based on a valid statistical rationale. 
 
We reviewed your firm’s response and conclude that it is not adequate. The response indicated that your firm plans to establish sampling plans based on (b)(4) by May 2013. However, your firm’s response failed to address procedural updates, including the revised sampling plan, and personnel training. 
 
8.    Failure to establish procedures for ensuring that all personnel are trained to adequately perform their assigned responsibilities and for identifying training needs, as required by 21 CFR 820.25(b). For example, your firm’s internal audit scheduled for 2013 included (b)(4) auditors. The auditors are management personnel who have not received training in conducting quality audits. 
 
The adequacy of your firm’s response cannot be determined at this time. Your firm’s response indicated that “documented training will take place” by May 2013. However, as of July 22, 2013, FDA has not received training records for review.
 
Our inspection also revealed that your firm’s Tampon and Applicator 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, maintain, and implement written MDR procedures, as required 21 CFR 803.17. For example, at the time of the inspection your firm’s employees confirmed that there are no written MDR procedures.
 
The U.S. 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 deviations 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, including 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 action (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.  Please provide a translation of documentation not in English to facilitate our review.
 
Your firm’s response should be sent to: Food and Drug Administration, Center for Devices and Radiological Health, Office of Compliance, Field Operations Branch, White Oak Building 66, Rm 2609, 10903 New Hampshire Ave., Silver Spring, MD 20993. Refer to CMS case # 398575 when replyingIf you have any questions about the contents of this letter, please contact: Debra E. Demeritt, Branch Chief at 301-796-5770. 
 
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/                                                           
Steven D. Silverman
Director
Office of Compliance
Center for Devices and
  Radiological Health
 
cc.
US Agent
Rene Van De Zande
Emerigo Group, Inc.
611 West 5th Street, Floor 3
Austin, Texas 78701