- Molteno Ophthalmic Limited
- Issuing Office:
- Center for Devices and Radiological Health
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||10903 New Hampshire Avenue|
White Oak Building 66
Silver Spring, MD 20993
FEB 27, 2015
VIA UNITED PARCEL SERVICE
Tess E.S. Molteno
Molteno Ophthalmic Limited
152 Frederick Street
Dear Mrs. Molteno:
During an inspection of your firm located at 152 Frederick Street, Dunedin 9016, New Zealand on October 28, 2014, through October 30, 2014, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the S-series and G-series glaucoma drainage implants. 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.
Our inspection revealed that your firm's S-series glaucoma drainage implants 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 under section 520(g) of the Act, 21 U.S.C. § 360j(g). Your firm's devices are also misbranded under section 502(o) the Act, 21 U.S. C. § 352(o), because your firm did not notify the agency of its intent to introduce the device into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k). Specifically, your firm has modified its G Series glaucoma drainage implants, cleared under K062252, by implementing a design change which included lowering the height of the pressure ridge and crest; increasing the surface area of the plate; and repositioning the suture holes closer to the drainage tube. Considering that the function of the plate is to initiate formation of the bleb, changes to the plate will impact the threshold for when aqueous fluid drains from the eye. Therefore, these modifications may impact the performance, safety and effectiveness of the device and a new 510(k) is required.
For a device requiring premarket approval, the notification required by section 510(k) is deemed satisfied when a Pre-Market Approval (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/MedicaiDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm
. The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.
In addition, this inspection noted nonconformances with regards to section 501 (h) of the Act (21 U.S.C. § 351 (h)), which are deficiencies within the firm's quality system pertaining to current good manufacturing practice requirements specified in the Quality System regulation found at 21 CFR Part 820.
We received your response, dated November 21, 2014, concerning our investigator's observations noted on the Form FDA 483 (FDA 483), List of lnspectional Observations, which was issued to your firm. We address this response below, in relation to each of the noted violations. These nonconformances include, but are not limited to, the following:
1. Failure to establish and maintain procedures for the identification, documentation, validation or where appropriate verification, review, and approval of design changes before their implementation, as required by 21 CFR 820.30(i).
For example, your firm implemented modifications to G-Series glaucoma drainage implants in 2011. However, your firm failed to validate or verify the design changes, as required by your firm's design and development planning procedures.
We reviewed your firm's response and conclude that it is not adequate. Your firm did not perform design validation to ensure that the design changes to the G-Series glaucoma drainage implants continue to perform as intended. Your firm's pyrogen testing did not evaluate endotoxin levels for segments of the implant (e.g. tubes) that come in contact with the anterior chamber of the eye. In addition, your firm did not conduct a retrospective review of design changes to ensure that they were adequately validated or verified prior to implementation.
2. Failure to establish and maintain 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. These 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, your firm's internal audit procedure does not require quality audits to be conducted by individuals who do not have direct responsibility for the matters being audited. During the 2014 internal audits, your firm's General Manager audited areas that were under her direct responsibility.
Your firm's response to this observation appears to be adequate.
Given the serious nature of the violations of the Act, the devices manufactured by your firm, including the G-Series and S-Series glaucoma drainage implants, 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 is taking steps to refuse entry of these devices into the United States, known as "detention without physical examination," until these violations are corrected. In order to remove the devices from detention, your firm should provide a written response to this Warning Letter as described above and correct the violations described in this letter. We will notify you regarding the adequacy of your firm's response and the need to re-inspect your firm's facility to verify that the appropriate corrections and/or corrective actions have been made.
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.
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 (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. Please provide a translation of documentation not in English to facilitate our review. We will notify you regarding the adequacy of your firm's response and the need to re-inspect your firm's facility to verify that the appropriate corrections and/or corrective actions have been made.
Your firm's response should be sent to: Food and Drug Administration, Center for Devices and Radiological Health, Office of Compliance, Field Inspections Support Branch, White Oak Building 66, Rm 2622, 10903 New Hampshire Ave., Silver Spring, MD 20993. Refer to CMS case #450427. If you have any questions about the contents of this letter, please contact: Daniel Walter, Chief, Foreign Enforcement Branch at telephone +1 (301) 796-5587, or fax +1 (301) 847-8139.
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 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 violations and bring the products into compliance.
Jan B. Welch, MHS, MT (ASCP) SBB
Office of Compliance
Center for Devices and
3184-B Airway Ave
Costa Mesa, CA 92626