Inspections, Compliance, Enforcement, and Criminal Investigations
Newman Lasik Centers, LLC 12/16/11
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|10903 New Hampshire Avenue|
Silver Spring, MD 20993
DEC 16 2011
VIA UNITED PARCEL SERVICE
Leonard A. Newman, M.D.
Newman Lasik Centers, LLC
500 Alfred Nobel Drive
Hercules, California 94547-1838
Dear Dr. Newman:
During an inspection of your firm located in Hercules, California, on August 8, 2011, an investigator from the United States Food and Drug Administration (FDA) determined that your firm is a medical device user facility and is subject to the statutory reporting requirements of the Medical Device Reporting (MDR) regulation, found at Title 21, Code of Federal Regulations (CFR) Part 803.
The ophthalmic laser used at your facility is a medical device under Section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h). This product is a device because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of disease, or it is intended to affect the structure or function of the body.
This inspection revealed that your facility’s 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. Significant violations include, but are not limited to, the following:
Failure to develop, maintain, and implement written Medical Device Reporting (MDR) procedures, as required by 21 CFR 803.17. In particular, there is no evidence that your facility’s MDR procedure has been implemented. For example, there is no effective date for the MDR procedure.
In addition, your facility’s MDR procedure fails to establish a process that provides for:
(1) A standardized review process or procedure for determining when an event meets the criteria for reporting under this part. For example, your facility’s procedure identifies (b)(4) as the primary individual responsible for making reportability decisions for adverse events. However, the procedure also states that, if (b)(4) are unavailable, an employee should fill out (b)(4) and report the event to FDA. It is not clear whether reportability decisions are being made by qualified personnel in (b)(4) absence.
(2) The procedure does not describe how your facility will address documentation and record-keeping requirements for:
- Information that was evaluated to determine if an event was reportable;
- All medical device reports and information submitted to the FDA; and
- Systems that ensure access to information that facilitate timely follow up and inspection by FDA.
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 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.
Your firm’s response should be sent to: Food and Drug Administration, Center for Devices and Radiological Health, Office of Surveillance and Biometrics, MDR Policy Branch, White Oak Building 66, 10903 New Hampshire Avenue, Room 3208, Silver Spring, MD 20993. Refer to the Unique Identification Number #247154 when replying. If you have any questions about the contents of this letter or wish to discuss MDR reportability criteria or schedule further communications, please contact: MDR Policy Branch at (301) 796-6670 or by email at MDRPolicy@fda.hhs.gov.
If your facility wishes to submit MDR reports via electronic submission, it can follow the directions stated at the following URL: http://www.fda.gov/MedicalDevices/deviceregulationandguidance/guidancedocuments/ucm094529.htm#where
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your 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, Form FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm. Your firm should investigate and determine the causes of the violations and take prompt actions to correct them to bring your products into compliance.
Steven D. Silverman
Office of Compliance
Center for Devices and