- International Medical Development Corporation
- Issuing Office:
- Denver District Office
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Denver District Office
Bldg. 20-Denver Federal Center
P.O. Box 25087
6th Avenue & Kipling Street
Denver, Colorado 80225-0087
September 17, 2015
RETURN RECEIPT REQUESTED
Mr. Walter Zohmann
International Medical Development Corp.
560 Highway 39
PO Box 510
Huntsville, UT 84317
Dear Mr. Zohmann:
During an inspection of your firm located in Huntsville, Utah on March 16, 2015 through March 19, 2015, investigators from the United States Food and Drug Administration (FDA) determined that your firm manufactures the Tuohy, Quincke, and Pencil Point needles sold under the trade name Gertie Marx (the “Gertie Marx Needles”). 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 any function of the body.
FDA has reviewed the inspection evidence, including packaging material, your firm’s website, (http://www.imd-inc.com), and other promotional materials and determined that the Gertie Marx Needles are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. 360j(g), for the device as described and marketed. The Gertie Marx Needles are also misbranded under section 502(o) of the Act, 21 U.S.C. 352(o), because your firm introduced or delivered for introduction into interstate commerce for commercial distribution these devices with major changes or modifications to the intended use without submitting a new premarket notification to FDA as required by section 510(k) of the Act, 21 U.S.C. 360(k), and 21 CFR 807.81(a)(3)(ii).
Specifically, the Gertie Marx Needles were cleared under K070354 for the transient delivery of anesthetics to provide regional anesthesia or to facilitate placement of an epidural catheter in adults. However, your firm’s promotion of the devices provides evidence that the devices are intended for lumbar puncture, myelogram, and pediatric use, which would constitute major changes or modifications to their intended use, for which your firm lacks clearance or approval. Examples include:
- A statement on your firm’s website that “[t]he line of Gertie Marx Pediatric Spinal Anesthesia needles for Lumbar Punctures are an invaluable tool for . . . pediatric anesthesiologists and neurologists.”
- Promotional material containing the statement: “The NEW Gertie Marx® Needle for Lumbar Puncture and Myelograms.”
- Outer packaging material containing the statement: “The NEW Gertie Marx® Needle For Pediatric Use.”
- Promotional material containing the statement: “The NEW Gertie Marx® Needle Anesthesia for Children Providing More Options for Helping the Children.”
For a device requiring premarket approval, the notification required by section 510(k) of the Act, 21 U.S.C. § 360(k), is deemed satisfied when a PMA is pending before the agency. 21 CFR 807.81(b). The kind of information that your firm needs to submit in order to obtain approval or clearance for the device is described on the Internet at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm. The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.
Our office requests that International Medical Development Corp. immediately cease activities that result in the misbranding or adulteration of the Gertie Marx Needles, such as the commercial distribution of the device for the uses discussed above.
Your firm should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties. Also, 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.
Please notify this office in writing within fifteen business days from the date you received 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 (which must address systemic problems) 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.
In addition, FDA has noted nonconformities with regard 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.
We have received your responses dated April 6, 2015, May 9, 2015, and June 24, 2015 concerning our investigators’ observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, which was issued to your firm. We address these responses below, in relation to each of the noted nonconformities. These nonconformities include, but are not limited to, the following:
1. Failure to establish and maintain procedures to control products that do not conform to specified requirements, as required by 21 CFR 820.90(a). Specifically, our review of your firm’s Nonconformance Logs revealed that your firm has failed to document any nonconforming product, but nine of (b)(4) device history records (DHRs) reviewed by the investigators were found to have labeling errors or discrepancies between the (b)(4). For example, DHR (b)(4) listed (b)(4) on the work order; however, only (b)(4) were listed as the final quantity received on the (b)(4) that your firm uses for its final quality control (QC) check. There is no documentation regarding the (b)(4). Per your verbal statements to the investigators, the (b)(4); however, this nonconformance was not documented or investigated, and there is no documentation regarding the disposition of the (b)(4).
At this time, we cannot determine the adequacy of your firm’s response. Your April 6, 2015 response indicated that you would revise your DHR documentation to include (b)(4), but your firm has not provided revised DHRs for our review. According to your May 9 and June 24, 2015 responses, your firm is working on establishing quality agreements with your vendors under which your firm will be (b)(4); however, until these have been completed and submitted for our review, we cannot evaluate the correction.
2. Failure to establish records of acceptable suppliers, contractors, and consultants, as required by 21 CFR 820.50(a)(3). Specifically:
a. Our review of your supplier audit reports for your top three suppliers revealed incomplete documentation, including, but not limited to, blanks or designations of “N/A” in the fields provided for numerous Quality System regulation requirements.
b. Your procedure, 501: Supplier Qualification/Audit Program, Rev. Initial Release, dated 10/18/2011, states that “a list of approved vendors, and their criticality should be established and maintained by QA.” However, your firm provided no documentation listing its approved suppliers/vendors, their criticality, or the type and extent of control to be exercised over them.
We reviewed your firm’s responses and concluded that they are not adequate. Although FDA investigators informed your firm’s management that your firm’s procedure regarding supplier qualification requires revision, your firm’s responses do not discuss any plans to revise that procedure, and we have not received a revised version of that procedure to review. In addition, your firm’s June 24, 2015 response stated that your firm had developed “a written list of approved vendors” and draft ranking as to their criticality and control, but your firm has not provided a copy of that list for our review.
3. Failure to document and to establish and maintain procedures for acceptance activities, as required by 21 CFR 820.80(a) and 21 CFR 820.80(e). For example:
a. Your firm failed to follow its procedures for sampling product for initial release for DHR (b)(4). Your firm’s procedure 801: Product/Component Receiving and Inspection, Rev. Initial Release, dated 10/18/2011, states that inspection should be performed using “(b)(4).” Based upon your firm’s procedure, 1501: Sampling plans, Rev. Initial Release, dated 10/18/2011, (b)(4) would require a sample size of (b)(4); however, documentation contained in DHR (b)(4) reflects that only (b)(4) were sampled for each of those lots.
b. The form containing the final QC check for packaging and labeling for lot #18776 was incomplete,although the lot was released for distribution. The form had no documentation of final review, no final approval signature, and no documentation of the quantity of product released for distribution.
We cannot determine the adequacy of your firm’s response at this time because your firm has not provided a detailed explanation of the corrective actions it will implement for our review. Additionally, although your firm’s management acknowledged failure to follow your firm’s established procedures, you have not provided any information regarding how you will ensure procedures are followed in the future.
4. Failure to maintain an adequate device history record, as required by 21 CFR 820.184. Specifically, of the (b)(4) DHRs reviewed by our investigators, none included, or referred to the location of, all elements required by 21 CFR 820.184 or by your firm’s own procedure, 1302: Device History Record (DHR), Rev. Initial Release, dated 10/18/2011, such as receiving/acceptance records, labels, labeling, and documentation of quantities released for distribution.
We cannot determine the adequacy of your response at this time. Your firm’s April 6, 2015 response stated that your firm would revise its DHRs to address this nonconformance, but your firm has not provided revised DHRs for our review. Your firm’s April 6, 2015 response also indicated that your firm would work with suppliers to ensure that (b)(4). You have not provided a detailed plan or specific timetable for implementation of these corrective actions. Your May 9, 2015 response indicated that your firm was revising SOP 1302, Device History Record; however, your firm has not provided the revised procedure for our review. Additionally, your response indicated that your firm has (b)(4) and that (b)(4) will require review and utilization of previously unused SOPs. You have not provided any details regarding which procedures will be used or any revisions to those procedures for our review.
5. Failure to maintain an adequate device master record, as required by 21 CFR 820.181. Specifically:
a. The information you presented to the investigators as your firm’s device master record (DMR) for Gertie Marx needles did not include complete documentation or refer to the location of all elements required by 21 CFR 820.181. For example, the DMR did not include, or refer to the location of, at least some device specifications (i.e., drawings and component specifications), production process specifications, quality assurance procedures and specifications, packaging and labeling specifications, and installation, maintenance and servicing procedures and methods.
b. Your firm’s procedure, 1301: Device Master Record (DMR), Rev. Initial Release, dated 10/18/2011, failed to list all elements required by 21 CFR 820.181, such as production process specifications, quality assurance procedures and specifications, packaging and labeling specifications, and installation, maintenance and servicing procedures and methods.
c. A formal DMR was not prepared and approved in accordance with 21 CFR 820.40, as required by 21 CFR 820.181.
We reviewed your firm’s responses and conclude that they are not adequate because this nonconformance was not addressed at all in those responses.
Your firm’s response should be sent to: Food and Drug Administration, Denver District, DFC, Bldg. 20, 6th Avenue and Kipling Street, P.O. Box 25087, Denver, CO 80225-0087, Attention: Sarah A. Della Fave, Compliance Officer. Refer to the identification number CMS Case # 456906 when replying. We remind you that only written communication is considered as official. If you have any questions about the contents of this letter, please contact Ms. Della Fave at (303) 236-3006.
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.
LaTonya M. Mitchell