• 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

Section Contents Menu

Enforcement Actions

Leisegang Feinmechanik-Optik GmbH 7/11/12

  

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

Public Health Service
Food and Drug Administration
 9200 Corporate Boulevard
Rockville MD 20850 

JUL 11, 2012

WARNING LETTER
 
 
VIA UNITED PARCEL SERVICE
 
Wolfgang Schmidt
General Manager
Leisegang Feinmechanik-Optik GmbH                                                                    
Leibnizstrasse 32
D-10625 Berlin, Germany
 
Dear Mr. Schmidt:
 
During an inspection of your firm located in Berlin, Germany, on April 16, 2012, through April 19, 2012, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the Leisegang Optik Model 1 and 2 coloposcope.  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 you and Mr. Thomas G. Williams, Vice President, Regulatory Affairs, and Business Assurance Official Correspondent of Cooper Surgical, Inc., dated May 9, 2012, 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 for implementing corrective and preventive action, as required by 21 CFR 820.100(a). For example:
 
a.  Your firm’s "Quality Management System Manual" Rev 4, dated August 08, 2011, § 7.5.1, "Corrective measures and preventive measures," is inadequate in that the manual:
 
i.  Only applies tocorrective and preventive actions (CAPA) resulting from customer complaints.  It does not define the requirements for analyzing other sources of quality data, e.g., processes, work operations, concessions, quality audit reports, quality records, etc.  According to the Quality System (QS) Management Representative, other quality data sources are identified in the management review procedure.
ii.  Does not include the requirements for investigating the cause of non-conformities relating to product, processes, and the quality system.
iii.  Does not include the requirements for verifying or validating the CAPA to ensure that such action is effective and does not adversely affect the finished device.
iv.  Does not include the requirements for implementing and recording changes in methods and procedures needed to correct and prevent identified quality problems.
v.  Does not include the requirements for ensuring that information related to quality problems or nonconforming product is disseminated to those directly responsible for assuring the quality of such product or the prevention of such problems.
 
b.  Regarding complaint no. (b)(4), dated (b)(4) in response to a complaint concerning a (b)(4), which (b)(4), your firm initiated a corrective action.  The corrective action taken was to fix the (b)(4). However, this record does not appear to include any documentation of the verification and/or validation of the corrective action to ensure that such action is effective and does not adversely affect the finished device and the record does not appear to include the changes in methods and/or procedures needed to correct the identified quality problems.
 
We reviewed your firm’s response and conclude that it is not adequate. Your firm is currently in the process of establishing an SOP to meet the requirements of 21 CFR 820.100. The SOP effective date of implementation is scheduled for (b)(4).  Your firm’s response, however, did not address the specific complaint cited in the observation and did not discuss a systemic corrective action. 
 
2.  Failure to 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, your firm’s VA 7.1, Rev 1, "Umgang mit kundenreklamationen" (handling of customer complaints), dated March 01, 2005, and F7-1 "Reklamationsbericht" (complaint report), dated March 15, 2005, are inadequate in that they do not ensure that:
 
a.  Complaints are processed in a timely manner.
b.  Complaints are evaluated to determine whether they represent an event which is required to be reported to FDA under 21 CFR Part 803.
c.  Complaints involving the possible failure of a device, labeling, or packaging to meet any of its specifications are reviewed, evaluated, and investigated.
d.  Complaints that represent an event which must be reported to FDA under 21 CFR Part 803 are promptly reviewed, evaluated, and investigated by designated individuals. The complaints need to be maintained in a separate portion of the complaints files or clearly identified.
e.  Records of investigations include the dates, results of the investigation, or any reply to the complainant.
 
We reviewed your firm’s response and conclude that it is not adequate. Your firm has acknowledged the lack of procedures for receiving, reviewing, and evaluating complaints by a formally designated unit. Your firm is currently in the process of correcting the deficiencies and anticipates that the procedures will require (b)(4) to write and implement. The effective date of implementation is scheduled for (b)(4). Your firm’s response, however, did not discuss a systemic corrective action to address the observation. 
 
3.  Failure to review and evaluate all complaints to determine whether an investigation is necessary. When no investigation is made, the manufacturer shall maintain a record that includes the reason that no investigation was made and the name of the individual responsible for the decision not to investigate, as required by 21 CFR 820.198(b).  For example, three complaints reviewed do not appear to document and implement the requirements of 21 CFR 820.198(b).  For example:
 
a.  Complaint no. (b)(4), dated (b)(4):  The reason for this complaint was a (b)(4). Your firm conducted an investigation that determined that the (b)(4), which caused (b)(4).  However, no investigation was recorded. Also, the response to the complainant does not appear to be included in the complaint record.
b.  Complaint no. (b)(4), dated (b)(4):  The reason for this complaint was a (b)(4), which (b)(4).  The complaint was evaluated to determine whether it represents an MDR-reportable event and does not appear to include a record of an investigation.
c.  Complaint no. (b)(4), dated (b)(4):  The reason for this complaint was that (b)(4). The firm conducted an investigation that determined that the (b)(4).  However, the investigation was not recorded.
 
We reviewed your firm’s response and conclude that it is not adequate. Your firm has acknowledged lack of procedures for receiving, reviewing, and evaluating complaints by a formally designated unit. Your firm is currently in the process of correcting the deficiencies and anticipates that the procedures will require (b)(4) to write and implement.  The effective date of implementation is scheduled for (b)(4). Your firm’s response, however, did not address the specific complaints cited in the observation and did not discuss a systemic corrective action. 
 
4.  Failure to establish and maintain procedures for the identification, documentation, validation or, where appropriate, verification, review, and approval of design changes before their implementation, as required by 21 CFR 820.30(i). For example, according to your firm’s Quality Management Representative, your firm has not established and maintained procedures for the identification, documentation, validation or, where appropriate, verification, review, and approval of design changes before their implementation.
 
We reviewed your firm’s response and conclude that it is not adequate. Your firm has acknowledged failure to adequately establish design change procedures. Your firm is currently in the process of correcting the deficiencies and anticipates that the procedures will require (b)(4) to write and implement.  The effective date of implementation is scheduled for (b)(4). Your firm’s response, however, did not discuss a systemic corrective action to address the observation. 
 
5.  Failure to establish and maintain adequate procedures to control product that does not conform to specified requirements, as required by 21 CFR 820.90(a). For example, your firm’s procedures VA 7.4, Rev 2, "Lenkung fehlerhafter Materialen und Produkte" (handling of defect materials and products), dated January 21, 2009, and F7-l, "Reklamationsbericht" (complaint report), dated March 15, 2005, are inadequate in that they do not:
 
a.  Address the evaluation and disposition of nonconforming product
b.  Provide that the evaluation of nonconformance should include a
determination of the need for an investigation and notification of the persons or organizations responsible for the nonconformance.
c.  Provide that the evaluation and any investigation should be documented.
 
We reviewed your firm’s response and conclude that it is not adequate. Your firm has acknowledged failure to adequately established procedures to control product that does not conform to specified requirements. Your firm is currently in the process of correcting the deficiencies and anticipates that the procedures will require (b)(4) to modify.  The effective date of implementation was scheduled for (b)(4). Your firm’s response, however, did not discuss a systemic corrective action to address the observation. 
 
6.  Failure to establish and maintain adequate procedures that define the responsibility for review and the authority for the disposition of nonconforming product, as required by 21 CFR 820.90(b)(1). For example, your firm’s procedures, VA 7.4, Rev 2, "Lenkung fehlerhafter Materialen und Produkte" (handling of defect materials and products), dated January 21, 2009, and F7-1, "Reklamationsbericht" (complaint report), dated March 15, 2005, are inadequate in that they do not:
 
a.  Define the responsibility for review and the authority for the disposition of nonconforming product.
b.  Set forth the review and disposition process.
c.  Provide that the disposition of nonconforming product should be documented, including the justification for use of nonconforming product and the signature of the individuals authorizing use.
 
We reviewed your firm’s response and conclude that it is not adequate. Your firm has acknowledged failure to adequately establish and maintain procedures that define the responsibility for review and the authority for the disposition of nonconforming product.  Your firm is currently in the process of correcting the deficiencies and anticipates that the procedures will require two months to modify.  The effective date of implementation is scheduled for July 1, 2012. Your firm’s response, however, did not discuss a systemic corrective action to address the observation. 
 
7.  Failure to establish and maintain adequate procedures for rework, to include retesting and reevaluation of the nonconforming product after rework, to ensure that the product meets its current approved specifications.  Rework and reevaluation activities, including a determination of any adverse effect from the rework upon the product, shall be documented in the device history records (DHRs), as required by 21 CFR 820.90(b)(2). For example, your firm’s procedures, VA 7.4 Rev 2, "Lenkung fehlerhafter Materialen und Produkte" (handling of defect materials and products), dated January 21, 2009, and F7-1, "Reklamationsbericht" (complaint report), dated March 15, 2005, are inadequate in that they do not:
 
a. Define the procedures for rework, to include retesting and reevaluation of the nonconforming product after rework.
b. Provide that rework and reevaluation activities should be documented in the DHR’s.
 
We reviewed your firm’s response and conclude that it is not adequate. Your firm has acknowledged failure to adequately establish and maintain procedures that define the responsibility for review and the authority for the disposition of nonconforming product.  Your firm is currently in the process of correcting the deficiencies and anticipates that the procedures will require (b)(4) to modify.  The effective date of implementation is scheduled for (b)(4). Your firm’s response, however, did not discuss a systemic corrective action to address the observation. 
 
8.  Failure to adequately establish and maintain adequate procedures to ensure that all purchased or otherwise received product and services conform to specified requirements, as required by 21 CFR 820.50. For example,your firm’s procedures, VA 5.1, Rev 0, "Lieferantenbewertung" (supplier evaluation), dated May 26, 2004, and VA 5.2, Rev 3, "Beschaffungvon Produkten" (purchasing of products), dated January 05, 2009, are inadequate in that they do not:
 
a.  Establish and maintain the requirements, including quality requirements that must be met by suppliers, contractors, and consultants. According to the QS Management Representative, VA 5.1, Rev 0, (b)(4).
b.  Provide for the evaluation and selection of potential suppliers, contractors, and consultants on the basis of their ability to meet specified requirements, including quality requirements, and assure that this evaluation should be documented.
c.  Define the type of and extent of control to be exercised over the product, services, suppliers, contractors, and consultants, based on the evaluation results.
 
We reviewed your firm’s response and conclude that it is not adequate. Your firm has acknowledged failure to adequately establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements. Your firm is currently in the process of correcting the deficiencies and anticipates that the procedures will require (b)(4) to modify.  The effective date of implementation is scheduled for (b)(4). Your firm’s response, however, did not discuss a systemic corrective action to address the observation. 
 
9.  Failure to maintain DHRs, as required by 21 CFR 820.184.  For example:
 
a.  The QS Management Representative stated that your firm did not establish procedures to ensure that DHRs for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the device master records (DMR’) and the requirements of 21 CFR Part 820.
b.  The DHRs for the (b)(4) did not include the primary identification label and labeling used for each production unit.
 
We reviewed your firm’s response and conclude that it is not adequate. Your firm has acknowledged failure to maintain DHRs. Your firm is currently in the process of correcting the deficiencies and anticipates that the procedures will require (b)(4) to modify.  The effective date of implementation is scheduled for (b)(4). Your firm’s response, however, did not discuss a systemic corrective action to address the observation. 
 
10.  Failure to establish procedures for quality audits, as required by 21 CFR 820.22. For example, "Quality Management System Manual", Rev 4, dated August 01, 2011, § 7.2.2, "Internal audits," are inadequate in that they do not:
 
a.  Cover all elements of the quality system; for example, the design control subsystem is not part of the audit plan.
b.  Define the conditions for re-audit of deficient matters.
 
We reviewed your firm’s response and conclude that it is not adequate. Your firm has acknowledged failure to establish procedures for quality audits. Your firm is currently in the process of correcting the deficiencies and anticipates that the procedures will require (b)(4) to modify.  The effective date of implementation is scheduled for (b)(4). Your firm’s response, however, did not discuss a systemic corrective action to address the observation. 
 
11.  Failure to ensure that all equipment used in the manufacturing process meets specified requirements and is appropriately designed, constructed, placed, and installed to facilitate maintenance, adjustment, cleaning, and use, as required by 21 CFR 820.70(g) (1). For example, your firm does not adequately define, document, and maintain schedules for the adjustment, cleaning, and other maintenance of equipment to ensure that manufacturing specifications are met, including: 

a.  Your firm does not have an equipment maintenance procedure, does not have a list of equipment requiring maintenance, and does not adequately document maintenance activities. For example:

    1. Equipment requiring maintenance is not identified with equipment numbers.
    2. The type of maintenance activity conducted is not documented. The (b)(4) only documents the initials of the individual conducting the maintenance activity under the (b)(4) the activity was conducted.  It does not contain the actual date the maintenance activity was conducted.
    3. The maintenance intervals for (b)(4) maintenance activities identified on the (b)(4) are not adequately defined.  According to this plan, the maintenance intervals for control of (b)(4).   However, the (b)(4)."  The Production Manager stated that this interval is also (b)(4).  However, this is not defined in the document. The maintenance interval for the control of security is (b)(4).  The Production Manager stated that this interval is also (b)(4). However, this is not defined in the document
b.  Your firm was not able to produce the maintenance records for the (b)(4), which is used to (b)(4), for the years (b)(4) and (b)(4).
 
c.  Your firm does not conduct periodic inspections in accordance with established procedures to ensure adherence to applicable equipment maintenance schedules.  Also, your firm does not define procedures for documenting the inspections, including the date and individuals conducting the inspections.
 
We reviewed your firm’s response and conclude that it is not adequate. Your firm has acknowledged failure to maintain schedules for the adjustment, cleaning, and other maintenance of equipment to ensure that manufacturing specifications are met. Your firm is currently in the process of correcting the deficiencies and anticipates that the procedures will require (b)(4) to modify. The effective date of implementation is scheduled for (b)(4). Your firm’s response, however, did not discuss a systemic corrective action to address the observation. 
 
Our inspection also revealed that your firm’s Leisegang Optik Model 1 and Leisegang Optik Model 2 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).  Significant violations include, but are not limited to, the following:
 
Failures to develop, maintain, and implement written MDR procedures as required by 21 CFR 803.17. For example, according to the QS Management Representative, your firm does not have an MDR procedure.
 
We reviewed your firm’s response and conclude that it is not adequate. Your firm has acknowledged failure to develop, maintain, and implement written MDR procedures. Your firm is currently in the process of correcting the deficiencies and anticipates that the procedures will require (b)(4) to modify.  The effective date of implementation is schedule for (b)(4). Your firm’s response; however, did not discuss a systemic corrective action to address the observation. 
 
A follow up inspection will be required to assure that corrections and/or corrective actions are adequate. 
 
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, Room 2609, 10903 New Hampshire Ave., Silver Spring, MD 20993. Refer to CMS case #305239 when replying. If you have any questions about the contents of this letter, please contact: Debra E. Demerittat 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:
 
Thomas G Williams
Leisegang's US Agent
CooperSurgical, Inc.
95 Corporate Dr
Trumbull, CT 06611