Inspections, Compliance, Enforcement, and Criminal Investigations
Go Medical Industries Pty., Ltd.12/23/11
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
10903 New Hampshire Avenue
DEC 23, 2012
VIA UNITED PARCEL SERVICE
Chief Executive Officer
Go Medical Industries Pty., Ltd.
200 Churchill Avenue
Western Australia 6008
Dear Ms. Graieg:
During an inspection of your firm located in Subiaco, Australia, on September 12 through September 14, 2011, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures flow control tubing, infusion pumps, and urological catheters. 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 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 ensure that when the results of a process cannot be fully verified by subsequent inspection and test, the process shall be validated with a high degree of assurance and approved according to established procedures, as required by 21 CFR 820.75(a). For example: the (b)(4) report for the catheters and catheter kits was provided for review; however, there were no procedures available for the (b)(4) study.
2. 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 does not monitor or act on bioburden data that has exceeded alert limits for products for private customers, even though the devices were manufactured at the contract manufacturer that manufactures Go Medical devices. Your firm only monitors and acts on bioburden data for Go Medical devices.
Our inspection also revealed that your firm's Flow Control Tubing is 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. Significant violations include, but are not limited to, the following:
Failure to adequately develop, maintain and implement written MDR procedures, as required by 21 CFR 803.17. For example, after reviewing your firm's MDR procedure entitled (b)(4) dated May, 2011, the !lowing issues were noted:
1. (b)(4) does not establish a process that provides for the timely and effective identification, communication, and evaluation of events that may be subject to MDR requirements. For example:
a. No definitions for what your firm will consider to be a reportable event under 21 CFR 803 were found in (b)(4). To facilitate the correct interpretation of reportable events and to assure the quality of MDR submissions, your firm's procedure should include the following definitions: become aware, caused or contributed, malfunction, MDR reportable event, serious injury, definitions for reasonably known which is found in 21 CFR 803.50(b), and reasonably suggests which is found in 21 CFR 803.20(c)(1).
b. (b)(4) does not include a process for identifying and evaluating events occurring outside the United States (U.S.) as potentially reportable to FDA. This process is required by 21 CFR 803.50 and 21 CFR 803.53. If an event occurs in a foreign country, it may be reportable under the MDR regulation if the event involves a device that is the same or similar to a device that has been cleared or approved in the U.S. and is also marketed in a foreign country.
2. (b)(4) does not establish a process that provides for a standardized review process or procedure for determining when an event meets the criteria for reporting under this part. For example:
a. There are no instructions for conducting a complete investigation of each event and evaluating the cause of the event, and
b. The procedure, as written does not specify who makes the decision for reporting events to the U.S. FDA.
3. Your firm's procedure does not establish a process that provides for the timely submission of complete medical device reports. Specifically, the following are not addressed:
a. Instructions for how to obtain and complete the FDA Form 3500A,
b. Instructions for how your firm will submit all information reasonably known for each event,
c. Circumstances under which your firm must submit initial, supplemental or follow-up reports and the requirements for such reports,
d. The address identifying where MDR reports should be submitted. The address for MDR submission is: FDA, CDRH, Medical Device Reporting, P.O. Box 3002, Rockville, MD 20847-3002, and
e. Process to submit reports for events that occur outside the U.S. If an event occurs outside of the US and involves a device that is the same or similar to a device that is cleared or approved for marketing approval in the U.S., then your firm must also evaluate these events for reportability and submit MDRs as required.
4. Your firm's procedure does not establish a process describing how documentation and record-keeping requirements will be addressed. Specifically, the following are not addressed:
a. Documentation of adverse event related information maintained as MDR event files,
b. Information that was evaluated to determine if an event was reportable,
c. Documentation of the deliberations and decision-making processes used to determine if a device-related death, serious injury, or malfunction was or was not reportable, and
d. Systems that ensure access to information that facilitates timely follow-up and inspection by FDA.
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 1 (301) 796-6670 or by email at MDRPolicy@fda.hhs.gov.
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 with in which these acti vities 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# 241874. If you have any questions about the contents of this letter, please contact: M. Isabel Tejera del Rio, General Hospital Devices Branch, at 1 (301) 796-5770 or via fax at 1 (301) 847-8137.
Finally, you shou ld 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 reg ulations administered by FDA. The specific violations noted in this letter and in the lnspectional 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 viola tions and bring the products into compliance.
Steven D. Silverman,
Office of Compliance
Center for Devices and
Radiologica l Health