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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Aurora Optics Company Inc 4/18/13

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 
New York District
158-15 Liberty Ave.
Jamaica, NY 11433

 April 18, 2013

WARNING LETTER NYK-2013-12

VIA United Parcel Service
 
Mr. Hokyong Won, Owner
Aurora Optics Company, Inc.
2205 121st Street, 2nd Floor
College Point, New York 11356
 
Dear Mr. Hokyong:
 
During an inspection of your firm located in College Point, New York on October 11 through 16, 2012, an investigator from the United States Food and Drug Administration (FDA) determined that your firm imports and distributes soft contact lenses. 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 any function of the body.
 
This inspection revealed that your firm’s soft contact lenses 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 with respect to the devices that is required under section 519 of the Act, 21 U.S.C. § 360i, and Title 21, Code of Federal Regulations (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. For example, your firm confirmed, during the inspection, that it had not developed an MDR Procedure.
 
Our inspection also 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 (CGMP) requirements of the Quality System (QS) 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 maintain complaint files and establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit for your “Hollow” and “Aurora” contact lenses, as required by 21 CFR 820.198(a).The procedures shall ensure that:  
 
a. All complaints are processed in a uniform and timely manner;
b. Oral complaints are documented upon receipt; and
c. Complaints are evaluated to determine whether the complaint represents an event which is required to be reported to FDA under Part 803, Medical Device Reporting.
 
  1. Failure to establish and maintain procedures for implementing corrective and preventive action for your "Hollow" and "Aurora" contact lenses as required by 21 CFR 820.100(a).
 
  1. Failure to establish and maintain procedures for acceptance activities. Acceptance activities include inspection, tests, or other verification activities as required by 21 CFR 820.80(a). Specifically, your firm does not have a written acceptance activities procedure established for "Hollow" and "Aurora" contact lenses
 
  1. Failure to establish and maintain procedures that address the identification, documentation, evaluation, segregation, and disposition of nonconforming product, as required by 21 CFR 820.90(a). Specifically, your firm does not have written non-conforming procedures established for their "Hollow" and "Aurora" contact lenses.
 
Our inspection also revealed that your firm’s “Hollow” and “Aurora” soft contact lenses are misbranded under section 502(b) of the Act, 21 U.S.C. § 352(b), in that the devices are in package form and their labels fail to contain the place of business of the manufacturer, packer, or distributor as required by 21 CFR 801.1(d).
 
Finally, our inspection also revealed that your firm’s “Hollow” and “Aurora” soft contact lenses are misbranded within the meaning of section 502(f)(1) of the Act, 21 U.S.C. § 352(f)(1), in that labeling of these devices fail to bear adequate directions for their intended uses. For example, its “Instructions for Use” is missing wearing Restrictions and Indications, Contraindications, and Warnings information according to the recommendations found in the May 1994 Premarket Notification [510k] Guidance Document for Class II Daily Wear Contact Lenses.
 
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.  Additionally, premarket approval applications for Class III devices to which the Quality System regulation violations 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 (15) 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 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. Your firm’s response should be comprehensive and address all violations included in this Warning Letter.
 
Your response should be sent to:
 
Lillian C. Aveta
Compliance Officer
New York District Office, Compliance Branch
Food and Drug Administration
158-15 Liberty Ave.
Jamaica, NY 11433
 
If you have any questions about the content of this letter please contact Ms. Aveta at 718-662-5576.
 
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, Form FDA 483 (FDA 483), issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality assurance systems. Your firm should investigate and determine the causes of the violations, and take prompt actions to correct the violations and to bring the products into compliance.   
 
Sincerely yours,
/S/ 
Ronald M. Pace
District Director
New York District