Inspections, Compliance, Enforcement, and Criminal Investigations
I.E.M. GmbH 2/12/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
10903 New Hampshire Ave.
February 24, 2012
VIA UNITED PARCEL SERVICE
Mr. Uwe Korth
Dear Mr. Korth:
During an inspection of your firm located in Stolberg, Germany, on October 17, 2011, through October 20, 2011, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures Class II Blood Pressure Monitors. 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.
Our inspection revealed that the your firm’s Class II Blood Pressure Monitoring 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. These violations include, but are not limited to, the following:
1. Failure to develop, maintain, and implement written MDR procedures, as required by 21 CFR 803.17.
For example, after reviewing your firm’s procedure entitled, “(b)(4) Rev l, Dokument: VA22_1-(b)(4).doc,” dated October 6, 2011, the following issues were noted:
a. VA22_1 does not establish internal systems that provide for timely and effective identification, communication, and evaluation of events that may be subject to MDR requirements; a standardized review process or procedure for determining when an event meets the criteria for reporting under this part; or timely transmission of complete medical device reports to FDA.
b. VA22_1 does not describe how your firm will document and maintain records. For example:
1. documenting and maintaining information that was evaluated to determine if an event was reportable;
2. maintaining records of all medical device reports and information submitted to FDA, and describing a system that ensures access to information that facilitates timely follow-up and inspection by FDA.
During the inspection, your firm provided a revised procedure dated October 17, 2011, entitled “(b)(4) - Rev J, Dokument: VA22_1-(b)(4) doc.” This revised procedure is still inadequate in that it fails to address the deficiencies noted above.
If your firm wishes to submit MDR reports via electronic submission it can follow the directions stated at the following URL:
If your firm wishes to discuss MDR reportability criteria or to schedule further communications, it may contact the MDR Policy Branch at 301-796-6670 or by email at MDRPolicy@fda.hhs.gov.
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 awarding 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 (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. Your firm’s response should be comprehensive and address all violations included in this Warning Letter. Please provide a translation of documentation not in English to facilitate our review.
In addition, FDA has noted nonconformances with regards to section 501(h) of the Act (21 U.S.C. § 351(h)), which are deficiencies within your firm’s quality system pertaining to current good manufacturing practice requirements specified in the Quality System regulation found at 21 CFR Part 820. These nonconformities include, but are not limited to, the following:
1. Failure to establish and maintain adequate procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a).
For example, your firm failed to issue a corrective and preventive action (CAPA) for a (b)(4) from a supplier, which was identified in engineering change order, ECO 20110125-1.
We reviewed your firm’s response dated November 8, 2011, and conclude that it is not adequate. During the inspection, your firm provided the investigator with an updated CAPA procedure and a newly-initiated CAPA 20111018-1 to address the supplier issue identified in ECO 20110125-1. However, your firm has not provided a systemic corrective action to include a retrospective review of additional engineering change orders that may need to be addressed through your firm’s CAPA system. Also, your firm has not provided evidence of implementation of the revised procedure to include training on the revised procedure.
2. Failure to adequately document corrective and preventive action activities and results, as required by 21 CFR 820.100(b).
For example: Engineering change order, ECO 20110411-01, and CAPA 11041101, identified a change to (b)(4) devices. However, the reason for the change was not identified in the CAPA, which is required by your firm’s CAPA procedure to ensure elimination of the problem.
We reviewed your firm’s response dated November 8, 2011, and conclude that it is not adequate. Your firm provided documentation on the decision-making process for CAPA 11041101 to include the reason for the change. However, your firm has not provided a systemic corrective action to include a retrospective review of additional engineering change orders and CAPAs to ensure that any changes have been adequately documented through your firm’s CAPA system. Additionally, your firm has not provided evidence of implementation of the revised procedure to include training records.
3. Failure to establish and maintain adequate procedures for acceptance of incoming product, which shall be inspected, tested, or otherwise verified as conforming to specified requirements, as required by 21 CFR 820.80(b).
a. There was no documentation that incoming lots of Mobil-O-Graph cuffs were tested to assure the cuffs met the specified requirement. Also, your firm did not provide certificates of conformance from the supplier to demonstrate that this requirement has been met, which is required by your procedures.
b. According to the manufacturing work instructions, “AA_09_05 (b)(4) BPC-T, Rev.G,” for the Stabil-O-Graphs, incoming (b)(4) used in the device are required to pass a (b)(4) test to be in compliance with your firm’s specifications. The investigator observed an (b)(4) fail the (b)(4) test; however, when the process identification number was scanned into your firm’s inventory system, an electronic label was generated, signifying that the module had passed the incoming acceptance test.
Your firm’s responses dated October 31, 2011, November 8, 2011, and December 1, 2011, do not address the first item in this observation.
We reviewed your firm’s response dated October 31, 2011, and conclude that it is not adequate. Your firm provided an updated version (Revision H) of the “AA_09_05 (b)(4) BPC-T” procedure and software verification test protocol for your firm’s inventory system. However, your firm has not provided a clear description of what revisions have been made to the updated work instructions and inventory system to ensure that future incoming (b)(4) that fail incoming testing are not used in the finished product packaging. There is also no evidence of implementation of the revised procedure to include training records. Additionally, your firm has not provided a description or evidence of implementation of a systemic corrective action to include the consideration of any acceptance activities that are performed for other components or devices to ensure their adequacy.
4. Failure to establish and maintain adequate data that clearly describe or reference the specified requirements, including quality requirements, for purchased or otherwise received product and services, as required by 21 CFR 820.50(b).
For example: In your firm’s Quality Assurance Agreement with cuff supplier (b)(4) under Section 3.4, (b)(4) the agreement states that (b)(4). During the review of your firm’s incoming documentation from this cuff supplier and during discussion with your firm, it was found that neither a Certificate of Conformance nor an OQA report had been supplied with the purchased products.
We reviewed your firm’s response dated December 1, 2011, and conclude that it is not adequate. Your firm provided an email as confirmation that the supplier, (b)(4), will supply a Certificate of Conformance or OQA report to your firm with all future deliveries. Additionally, your firm provided a copy of a recent OQA report, dated November 31, 2011, from (b)(4). However, your firm failed to provide documentation or evidence of implementation of a corrective action explaining how your firm will handle purchasing data in the future to ensure that purchased products and services have met specified requirements. Additionally, your firm has not provided documentation or evidence of implementation of a systemic corrective action to include the consideration of purchasing requirements specific to other supplied products or services.
5. 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, including determination of any adverse effects from the rework upon the product, which shall be documented in the Device History Record (DHR), as required by 21 CFR 820.90 (2)(b).
For example: Your firm initiated rework of its Mobil-O-Graph cuffs, which included (b)(4). The only documentation of this rework provided by your firm is training documentation titled, (b)(4),” dated May 5, 2010. Rework activities conducted for the Mobil-O-Graph cuffs were not documented in the DHR and these changes were not retested or reevaluated to ensure that the product met its original specifications.
We reviewed your firm’s response dated October 31, 2011, and conclude that it is not adequate. Your firm provided an updated version (Revision G) of SOP “VA13_1 (b)(4) dated October 31, 2011, that clarifies the review, approval, and record of future modifications and any corresponding validation activities. However, your firm has not provided evidence of implementation of this procedure for the rework of the Mobil-O-Graph cuffs to include the review and approval of the rework process and validation activities for this rework process. Your firm has not provided evidence of implementation of the revised procedure to include training records. Additionally, your firm has not provided a description or evidence of implementation of a systemic corrective action to include the consideration of all rework processes performed on all medical device models that your firm manufacturers.
Your firm’s response to this letter 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 the Unique Identification Number CMS case # 276156 when replying. If you have any questions about the contents of this letter, please contact: Joshua Simms, Branch Chief of Cardiac Rhythm and Electrophysiology Devices Branch, at 301-796-5599.
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.
Steven D. Silverman
Office of Compliance
Center for Devices and Radiological Health