|Company:||Apia Enterprise Inc|
|Subject:||Medical Device Reporting/Misbranded|
|Issuer:||Los Angeles District Office|
|Issued:||June 28, 2012||Closed:||
Department of Health and Human Services
Public Health Service
Food and Drug Administration
Los Angeles District
Irvine, CA 92612-2506
VIA UNITED PARCEL SERVICE
June 28, 2012
Kyung Ok Kang, Owner
Apia Enterprise Incorporated
12611 Hidden Creek Way, Suite C
Cerritos, California 90703
Dear Mr. Kang:
During an inspection of your establishment located in Cerritos, California, on November 29-30, 2011, 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.
Our inspection revealed that your 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 respecting the devices that is required by or 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 deviations include, but are not limited to:
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.
We reviewed your firm's response and concluded that it is not adequate. The response, received by the Los Angeles District Office on December 23, 2011, included an MDR procedure titled "Complaint and MDR Procedure." The response is inadequate for the following reasons:
1. There is no evidence that your firm's MDR procedure has been implemented. For example, there is no "Prepared by" or "Approved by" date for your firm's MDR procedure.
2. The procedure does not establish internal systems that provide for timely and effective identification, communication, and evaluation of events that may be subject to MDR requirements. For example, the procedure does not address:
Definitions of what your firm will consider to be a reportable event under 21 CFR Part 803. To facilitate the correct interpretation of reportable events and to assure the quality of MDR submissions, the procedure should include definitions based on 21 CFR 803.3 for the terms "become aware," "caused or contributed," "malfunction," "MDR reportable event," "serious injury," and the definition for the term "reasonably suggests," found in 21 CFR 803.20(c)(1).
3. The procedure does not establish internal systems that provide for a standardized review process to determine when an event meets the criteria for reporting under this part. For example:
The procedure does not state who makes the reportability decision. The "MDR Reporting" section of the procedure states that any alpha industry employee must complete MedWatch forms within 30 days of receiving information regarding an MDR reportable event. It is not clear who the alpha industry employee refers to as it is not the name of your firm. Please note that, per 21 CFR 803.20(c)(2), the decision to file or not file an MDR should be made by a person who is qualified to make such decisions.
4. The procedure does not establish internal systems that provide for timely transmission of complete medical device reports. Specifically, the following are not addressed:
• The types of information to be included on the FDA Form 3500A;
• The address for where to submit MDR reports: FDA, CDRH, Medical Device Reporting, P.O. Box 3002, Rockville, MD 20847-3002;
• Although your firm's procedure references time frames in which your firm must submit initial MDR reports to the FDA, the procedure does not stipulate calendar days, as specified in 21 CFR 803.40.
5. The procedure does not include a description of how your firm will address documentation and record-keeping requirements, including:
• 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;
• Systems that ensure access to information that facilitates timely follow up and inspection by FDA.
Your firm's procedure includes references to baseline reports. As an importer, the requirement to submit a baseline report does not apply. In addition, baseline reports are no longer required to be submitted to FDA by manufacturers. We recommend that all references to a Baseline Report be removed from your firm's MDR procedure (see: 73 Federal Register Notice 53686, dated September 17, 2008).
Your firm's procedure includes a reference to annual certification requirements. As an importer, the requirement to submit an annual certification does not apply. In addition, the requirement for annual certification by manufacturers is no longer required. We recommend that all references to annual certifications be removed from your firm's MDR procedure (see: Fourth Notice, Federal Register, dated March 20, 1997: Medical Device Reporting; Annual Certification; Final Rule).
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 301-796-6670 or by email at
Our inspection also revealed that your soft contact lenses are misbranded under section 502(f)(1) of the Act, 21 U.S.C. § 352(f)(1), in that the labeling for these devices fails to bear adequate directions for use for the purposes for which they are intended. Specifically during this inspection, your firm's product labels were examined. Our evaluation found that, while the labeling contains some of the elements required of FDA-cleared or approved contact lenses, it is paraphrased, incomplete, and inaccurate in detail. Specifically, it does not contain a professional fitting guide, which is necessary as these are prescription devices. Moreover, the patient labeling does not identify care instructions for cleaning, disinfection, or wearing schedules. Additionally, the labeling does not include specific precautions or warnings. Examples of FDA-recommended precautions or warnings include statements informing consumers of the following:
• A consumer who develops an eye infection to immediately remove their lenses and promptly contact their eye care provider;
• Not to reuse or "top off' old solution left in lens cases since solution reuse reduces effective lens disinfection and could lead to severe infection, vision loss or blindness;
• To rub and rinse the lenses for the amount of time recommended by the manufacturer to help prevent serious eye infections;
• Not to store lenses or rinse lens cases with water or any non-sterile solution.
For detailed information on FDA-recommended labeling for your product, please refer to the following URL: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments /UCM223665.pdf
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: D. S. Food and Drug Administration, Los Angeles District Office, 19701 Fairchild, Irvine, CA 92612. Refer to the Unique Identification Number (CMS case# 294497) when replying. If you have any questions about the contents of this letter, please contact: Dr. Raymond W. Brullo, Compliance Officer at 949-608-2918.
In addition, FDA noted nonconformances with regards 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. These nonconformities include, but are not limited to, your firm's failure to establish and maintain adequate procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a). For example, your firm is listed as the distributor of the contact lenses on the product's labeling. However, during the inspection, representatives of your firm stated that it did not have a complaint handling procedure and that staff members were not aware of the requirements for complaint handling.
We reviewed your firm's response and concluded that it is not adequate. Your firm submitted a complaint form as part of this response. However, your firm's response did not include any written procedures for review, investigation, evaluation, and mitigation of complaints. Additionally, your firm did not address whether training will be provided to employees in the complaint handing procedure.
The inspection also revealed that your firm is selling lenses that are grey, dark grey, turquoise, violet, honey, hazel, and eagle. The devices sold by your firm under 510(k) #K020608 have been cleared for Phthalcyaninc Blue, Phythalacyaninc Green, and Phthalocyanine Titanium Oxide. We request that you provide us with the names of the FDA-approved color additives for the colors being used in your firm's products. If you do not believe that you are required to use FDA-approved color additives for your firm's products, please provide us with the basis for that determination.
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.
Alonza E. Cruse, Director
Los Angeles District
Cc: Ingeborg Small, Branch Chief
Food and Drug Branch
California Department of Public Health
1500 Capitol Ave. MS 7602
P.O. Box 997413
Sacramento, CA 95899-7413