Inspections, Compliance, Enforcement, and Criminal Investigations
DMC Medical Ltd 5/24/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
10903 New Hampshire Avenue
May 24, 2012
VIA UNITED PARCEL SERVICE
Mr. Bryan Wixted
DMC Medical Ltd.
Unit 2 Abbey House, Shannon Town Centre
Clare County, Ireland
Dear Mr. Wixted:
During an inspection of your firm located in Clare County, Ireland, on February 20, 2012, through February 22, 2012, an investigator from the United States Food and Drug Administration (FDA) determined that your firm is the corporate office and serves as the specification developer for several Class I and II medical devices, including polycarbonate syringes, polycarbonate connectors, vein irrigation cannulas, HeartNet heat positioning devices, cardiac insulation pads, and saphenous vein distention systems. 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. These violations include, but are not limited to, the following:
1. Failure to adequately establish and maintain procedures to ensure that the design requirements relating to a device are appropriate and address the intended use of the device, including the needs of the user and patient, as required by 21 CFR 820.30(c).
For example, Design Control Procedure (QAP045, Rev. New), Section 3.2.1, Product performance specification, requires a document that translates the customer specifications to engineering terms. The document shall include both system and component performance specifications, and the specifications will be detailed under the following headings: physical, chemical, biological, packaging, sterilization, label claims, and functionality.
Each specification will include the verification test method and acceptance criteria. However, the Product Performance Specification (Polycarbonate Syringe Range, Output document #10, dated December 14, 2004) includes only (b)(4) requirements. This document does not include the other requirements as specified in your procedure (i.e., (b)(4)). You provided a document from the design history file (DHF) that includes some of the specifications (e.g., physical, chemical, and biological); however, this document is not signed off as having been reviewed and approved by management. The List of Contents for this DHF identifies this document as Document E - Product Description. It is unclear when the Product Description document was generated and/or added to the DHF, because the Product Description document is not dated.
2. Failure to adequately establish and maintain procedures for defining and documenting design output in terms that allow an adequate evaluation of conformance to design input requirements, as required by 21 CFR 820.30(d).
For example, Design Control Procedure (QAP045, Rev. New), Section 3.2.2, Component Design, states that design efforts will result in the manufacturing documents that describe the product and include component drawings, assembly drawings, contract reviews, and raw material specifications. However, the System & Component Specification (Polycarbonate Syringe Range, Output document #11, dated December 14, 2004) that you provided as the document that fulfills this requirement indicates that component performance is laid out in accordance with current (b)(4). The only (b)(4) that you provided was not approved until November 11, 2006. This is well after the date Output Document #11 was signed (December 14, 2004). The (b)(4) was not completed until 2006; therefore, reference to the (b)(4) within the DHF is not appropriate because the (b)(4) did not exist in December 2004.
3. Failure to establish and maintain procedures to ensure that formal documented reviews of the design results are planned and conducted at appropriate stages of the device's design development, as required by 21 CFR 820.30(e).
For example, there was no documentation that design reviews were completed as required by Design Control Procedure (QAP045, Rev. New) following Stages 2 (Design Verification), 3 (Design Validation), and 4 (Process Validation) of the Polycarbonate Syringe Range design project.
4. Failure to adequately establish and maintain procedures for verifying the device design. Design verification shall confirm that the design output meets the design input requirements, as required by 21 CFR 820.30(f).
For example, Design Control Procedure (QAP045, Rev. New), Section 3.2.10, Design Review I, states that the design review will confirm that design specifications meet customer and mandatory requirements, and that the product is safe and effective for its intended purpose. All relevant documents will be kept in the DHF. However, Stage 2- Design Verification was signed as completed on December 14, 2004. The document identified by your firm as containing the design outputs was the (b)(4) , which should have been utilized to compare design outputs with design inputs for design verification of the Polycarbonate Syringe Range, and which was not approved until November 11, 2006.
5. Failure to adequately establish and maintain procedures for validating the device design, as required by 21 CFR 820.30(g).
For example, Design Control Procedure (QAP045, Rev. New), Section 3.3- Design Validation, states that the objective of this stage is to validate the product specifications through customer feedback during human-use trials. No documentation was available in the DHF for the Polycarbonate Syringe Range design project to support completion of design validation.
6. Failure to adequately establish and maintain procedures to ensure that the device design is correctly translated into production specifications, as required by 21 CFR 820.30(h).
For example, Design Control Procedure (QAP045, Rev. New), Section 3.4- Stage 4, includes requirements to: (b)(4) (Section 3.4.1); (b)(4) (Section 3.4.2); (b)(4) (Section 3.4.3); (b)(4) (Section 3.4.4); and (b)(4) (3.4.5). The document titled "Transfer Specifications to Manufacturer for PC Syringe Range" (Polycarbonate Syringe Range, Output document #29, dated January 28, 2005) states that all product specifications have been verified, double checked, and signed off. Specifications are in the form of (b)(4); the only (b)(4) provided by your firm was not approved until November 11, 2006. The (b)(4) could not have been verified, double checked, and signed off as described in Output Document #29 because the (b)(4) did not exist until November 2006.
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 # 291559 when replying. If you have any questions about the contents of this letter, please contact: Debra Demeritt, Acting Branch Chief, General Hospital Devices Branch at 301-796-5770 or 301-847-8137.
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
Ms. Charmaine Henderson