Inspections, Compliance, Enforcement, and Criminal Investigations
Bauer & Hasselbarth Gmbh 12/22/10
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
10903 New Hampshire Avenue
December 22, 2010
Via United Parcel Service
Mr. Stefan Lenz
Bauer & Haselbarth - Chirurg - Gmbh
25479 Ellerau, Germany
Dear Mr. Lenz:
During an inspection of your firm located in Ellerau, Germany on September 13–16, 2010, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures Tracheal Tubes, and Vaginal & Rectal Specula. 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 manufacture, packing, storage, or installation are not in conformity with the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation found at Title 21, Code of Federal Regulations (CFR), Part 820. We received a response from Manfred Salamon, Director R&D & QA dated September 29, 2010 concerning our investigator’s observations noted on the Form FDA 483, List of Inspectional Observations that was issued to you. 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 adequately ensure that when the results of a process cannot be fully verified by subsequent inspection and test that the process is validated with a high degree of assurance and approved according to established procedures, as required by 21 CFR 820.75(a). For example, the processes used in the induction welding process have not been validated. There is no documentation to support the parameters used in the (b)(4) welding processes are validated.
Your firm provided no response to this QS regulation violation identified in the review of your Establishment Inspection Report.
2. Failure to establish and maintain adequate procedures for implementing corrective and preventive action to include analyzing processes, work operations, concessions, quality audit reports, quality records, service records, complaints, returned product, and other sources of quality data to identify existing and potential causes of nonconforming product, or other quality problems, as required by 21 CFR 820.100(a)(1). For example, your firm has not been analyzing non-conformance (internal complaint) information to identify existing or potential causes of the nonconforming product. Not all non-conformances identified during finished product inspections (e.g. product associated with rework orders) are handled under the non conformance (internal complaint) procedure.
We reviewed your response and concluded the adequacy cannot be determined at this time. Your firm provided a revision of “Instructions for Procedure – VA.832 Managing Defective Products Decision Request/Complaint”, QMM Revision D, dated September 28, 2010. This procedure discussed error/fault findings and information transfer (internal complaint). However, your firm did not provide evidence of implementation of the corrective action to ensure internal complaints are used to identify existing and potential causes of nonconforming products.
3. Failure to establish and maintain adequate procedures for implementing corrective and preventive action that include identifying the action(s) needed to correct and prevent recurrence of nonconforming product and other quality problems, as required by 21 CFR 820.100(a)(3). For example:
•18 rework orders observed since January 2010 for the Weitlaner retractors identified non conformance due to the presence of rust on the devices. However, there was no documentation of an investigation to identify appropriate corrective actions.
•Corrective and preventive actions that have been made pertaining to external and internal complaints have not had documented investigations and have not included verification of corrective actions.
We reviewed your response and concluded that it is not adequate. Your firm revised “Instructions for Procedure VA.832 Managing Defective Products Decision Request/ Complaints”, Revision D, Dated September 28, 2010” for the handling of internal and external complaints. Your firm stated this procedure is currently being followed and will be reviewed for its effectiveness and compliance. However, your firm did not provide evidence that the 18 Weitlaner retractor rework orders were adequately investigated to identify appropriate corrective actions.
4. Failure to develop, conduct, control, and monitor production processes to ensure that a device conforms to its specifications. Where deviations from device specifications could occur as a result of the manufacturing process, the manufacturer shall establish and maintain process control procedures that describe any process controls necessary to ensure conformance to specifications, as required by 21 CFR 820.70(a). Specifically, the (b)(4) (welding process used for (b)(4) (welding) of components for various assemblies is not consistently using the recommended settings that are maintained in (b)(4). For example:
• The (b)(4) indicates the time setting as (b)(4) minutes and the Power setting as (b)(4). However, the production staff is using (b)(4) minutes for the elapsed time with a power of (b)(4).
• The Power (b)(4) was changed from (b)(4) to (b)(4) (used for article (b)(4)).
• There is no procedure to provide guidance for the permissible adjustment of the process parameters and to establish acceptable working ranges specific to the (b)(4) welding process.
We reviewed your response and concluded that it is not adequate. Your firm provided procedure “QS – SOP – QSA 04-04, “((b)(4) (b)(4))” Dated September 20, 2010”. However, this procedure did not provide adequate guidance for the permissible adjustment of the process parameters or acceptable working ranges specific to the (b)(4) welding process. Additionally, your firm provided no evidence of implementation for the corrective actions to ensure the production staff is currently using the correct time and power settings for the (b)(4) welding process.
5. Failure to establish and maintain adequate procedures to control product that does not conform to specified requirements. The procedures shall address the identification, documentation, evaluation, segregation, and disposition of nonconforming product. The evaluation of nonconformance shall include a determination of the need for an investigation and notification of the persons or organizations responsible for the nonconformance. The evaluation and any investigation shall be documented, as required by 21 CFR 820.90(a). Specifically, rework orders made as a result of non conformance for sharp or rough surfaces of vaginal or rectal specula have not been investigated to identify the cause of the nonconformities. For example:
• Rework Order (b)(4) documents that on final inspection, (b)(4) pieces of Vaginal Specula were identified that were not adequately deburred. There was no investigation to determine why the processes to adequately prepare the surface were not effective.
• Rework order (b)(4) documents that on June 28, 2010 final inspection identified (b)(4) pieces of Beckman rectal specula had prongs that were too sharp.There was no investigation to determine why the product had not been finished correctly.
We reviewed your response and concluded that it is not adequate. Your firm revised “Instructions for Procedure VA.832 Managing Defective Products Decision Request/ Complaints”, Revision D, Dated September 28, 2010” for the handling of internal and external complaints. Your firm stated this procedure is currently being followed and will be reviewed for its effectiveness and compliance. However, your firm did not provide evidence that the Rework Orders for (b)(4) and (b)(4) were adequately investigated to identify cause of the nonconformities.
6. Failure to establish and maintain adequate procedures for finished device acceptance to ensure that each production run, lot, or batch of finished devices meets acceptance criteria, as required by 21 CFR 820.80(d). Specifically, the finished device inspection of Vaginal and Rectal Specula do not fully document inspection of devices for sharp or rough edges on the surface. For example:
• Work Order (b)(4) for the Brinkerhoff Rectal Specula only includes documentation of the dimension characteristics of the device.
• Work Order (b)(4) for the Auvard Vaginal Specula has a notation that devices should be free from sharp edges but does not document that each piece is inspected.
• Work Order (b)(4) for the Trelatt Vaginal Specula does not document that the devices have been inspected for sharp or incorrect surfaces or edges.
We reviewed your response and concluded that it is not adequate. Your firm provided corrections using CAPA plan No. (b)(4). This CAPA states your firm will use a computer system to store inspection results and to monitor data processing for corrective action planning. However, your firm did not provide evidence of implementation for the corrective actions to ensure Work Orders (b)(4), (b)(4), and (b)(4) met acceptance criteria as finished devices.
7. Failure to establish and maintain adequate procedures to ensure that device history records for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the device master record, as required by 21 CFR 820.184. Specifically, not all device history records are complete and demonstrate that all processing steps have been completed. For example, device history records for work order numbers (b)(4), (b)(4), and (b)(4) for Brinkerhoff Rectal Specula were released for distribution with largely incomplete documentation of the completion of specified processing steps.
We reviewed your response and concluded that the adequacy cannot be determined at this time. Your firm provided an instruction document to identify documents belonging to the devices and to ensure manufacturing steps are properly fill-in and signed. Additionally, your staff was trained on the instructions for handling shop orders (manufacturing papers) on September 21, 2010. However, your firm did not submit any documentation specific to the implementation of the corrective action.
8. Failure to establish adequate procedures for quality audits and conduct such audits to assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system. Quality audits shall be conducted by individuals who do not have direct responsibility for the matters being audited, as required by 21 CFR 820.22. For example, the Director R&D and QA is performing the internal audits for the Design areas, Non Conformance, Quality Monitoring and CAPA. However, the Director of R&D and QA is directly responsible for each of these audited areas.
Your response to this observation appears to be adequate. Your firm has rewritten the 2010 audit plan and assigned a new medical engineer to conduct the audits who does not have direct responsibility for the matters being audited.
Our inspection also revealed that your Tracheal Tubes, and Vaginal & Rectal Specula devices are misbranded under section 502(t)(2) of the Act 21 USC 352 (t)(2), in that your firm failed or refused to furnish material or information respecting the devices that is required by under section 519 of the Act, 21 USC 360i, and 21 CFR Part 803 – Medical Device Reporting (MDR) Regulation. Significant deviations include, but are not limited to:
Failure to develop, maintain and implement written MDR procedures as required by 21 CFR Part 803.17. As a manufacturer, you must develop, maintain, and implement written MDR procedures for the following:
(a) Internal systems that provide for:
(1) Timely and effective identification, communication, and evaluation of events that may be subject to MDR requirements;
(2) A standardized review process or procedure for determining when an event meets the criteria for reporting under this part; and
(3) Timely transmission of complete medical device reports to manufacturers or to us, or to both if required.
(b) Documentation and recordkeeping requirements for:
(1) Information that was evaluated to determine if an event was reportable;
(2) All medical device reports and information submitted to manufacturers and/or us.
We reviewed your response dated September 29, 2010, and concluded that it is not adequate because procedure “VA 830 Observation and Reporting System Harmonized with MPS and FDA-MDR” does not address the above requirements.
Please note that your procedure contains reporting requirements for other regulatory or competent authorities. To insure that your firm can meet its regulatory obligations for 21 CFR Part 803, we highly recommend that you develop your MDR procedure as a separate document.
If your firm wishes to submit MDR reports via electronic submission you can follow the directions stated at the following URL:
If you wish to discuss MDR reportability criteria, you may contact Sharon Kapsch, Branch Chief; Reporting Systems Monitoring Branch, to schedule further communications, at 301-796-6104 or by email at Sharon.Kapsch@fda.hhs.gov.
Given the serious nature of the violations of the Act, the Tracheal Tubes, and Vaginal & Rectal Specula manufactured by your firm are subject to refusal of admission under section 801(a) of the Act, 21 U.S.C. § 381(a), in that they appear to be adulterated. As a result, FDA may take steps to refuse these products, known as "detention without physical examination," until these violations are corrected. In order to remove the devices from detention, you should provide a written response to this Warning Letter as described below and correct the violations described in this letter. We will notify you if your response is adequate, and we may need to re-inspect your facility to verify that the appropriate corrections have been made.
Also, U.S. 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, 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 (15) working days from the date you receive this letter of 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 action 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, state the reason for the delay and the time within which the corrections will be completed. Please provide a translation of documentation not in English to facilitate our review.
Your response should be sent to: Paul F. Tilton, Chief, Ob/Gyn, Gastroenterology, and Urology Devices Branch, WP66-3540, 10903 New Hampshire Avenue, Silver Spring, Maryland, 20993, U.S.A. If you have any questions about the content of this letter please contact: Ronald T. Nowalk at (telephone) 301-796-5493 or (fax) 301-847-8137.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your facility. 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 (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 and to bring your products into compliance.
Steven D. Silverman
Office of Compliance
Center for Devices and