Pishon Trading Inc 1/30/13
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||Los Angeles District|
Irvine, CA 92612-2506
VIA UNITED PARCEL SERVICE
January 30, 2013
Steve S. Park, President
Pishon Trading Inc dba Eyezone
10600 Shoemaker Ave, Suite C
Santa Fe Springs, California 90670-4073
Dear Mr. Park:
During inspections of your establishment located in Santa Fe Springs, California, on November 22 – December 07, 2011 and July 18 – August 01, 2012, investigators from the United States Food and Drug Administration (FDA) determined that your firm imports and distributes soft contact lenses also known as decorative 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 inspections 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 inspections, that it had not developed an MDR Procedure.
We note that you did not respond to the FDA 483 issued to your firm on December 07, 2011. We reviewed your firm’s response received by the Los Angeles District Office on October 26, 2012 and concluded that it is not adequate. You did not address the MDR procedure deficiency. 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 MDRPolicy@fda.hhs.gov.
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 these inspections, 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:
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’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 including, but not limited to, aqua, blue, blue sapphire, dark gray, dark violet, gray, green, hazel, honey, jade, magic angel, misty blue, misty green, misty hazel, pearl gray, pure hazel, sky blue, sweety gray, turquoise, and violet. The devices sold by your firm under 510(k) #K002099 have been cleared for Phthalocyaninc Blue, Phythalocyaninc Green, and Titanium Dioxide. 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.
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:
Blake Bevill, Director Compliance Branch
U. S. Food and Drug Administration
Los Angeles District Office
19701 Fairchild, Irvine, CA 92612.
Refer to the Unique Identification Number (CMS case # 375538) 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 or firstname.lastname@example.org.
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
Patrick Kennelly, Acting Branch Chief
California Department of Public Health
Food and Drug Branch
PO Box 997435
1500 Capitol Avenue, MS-7602
Sacramento, CA 95899-7413