Inspections, Compliance, Enforcement, and Criminal Investigations

9mm Special Effects 5/19/15

  

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

Public Health Service
Food and Drug Administration
 San Francisco District
1431 Harbor Bay Parkway
Alameda, CA 94502-7070
Telephone: (510) 337-6700 

 

WARNING LETTER
 
May 19, 2015 
 
VIA UNITED PARCEL SERVICE
Signature Required, and E-mail
 
Kevin S. Carter
President/Owner
9mm Special Effects
415 Dairy Rd, Suite E
Kahului, HI 96732
 
 
Dear Mr. Carter:
 
During an inspection of your firm located in Haiku, Hawaii on September 8, 2014 through September 30, 2014, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures decorative contact lenses.  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 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.
 
Unapproved Device
 
The Act requires that manufacturers of devices that are not exempt obtain marketing approval or clearance for their products from the FDA before they may offer them for sale. This helps protect the public health by ensuring that new devices are shown to be both safe and effective or substantially equivalent to other devices already legally marketed in this country for which approval is not required.
 
The inspection revealed that you have not obtained marketing approval or clearance before you began offering your product for sale, which is a violation of the law. Specifically, your decorative contact lenses 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). 
 
The device is 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).  For a device requiring premarket approval, the notification required by section 510(k) is deemed satisfied when a 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/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm. The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.
 
Quality System Regulation
 
The inspection revealed that your 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 requirements of the Quality System 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 establish and maintain procedures for implementing corrective and preventive actions as required by 21 CFR 820.100.
 
2.    Failure to establish and maintain procedures to control the design of the device in order to ensure that specified requirements are met as required by 21 CFR 820.30(a).
 
3.    Failure to ensure that when the results of a process cannot be fully verified by subsequent inspection and test, the process shall be validated with a high degree of assurance and approved according to established procedure, as required by 21 CFR 820.75(a). 
 
4.    Failure to develop, conduct, control, and monitor production processes to ensure that a device conforms to its specifications, as required by 21 CFR 820.70(a). 
 
5.    Failure to establish quality system procedures and instructions as required by 21 CFR 820.20(e). 
 
6.    Failure to establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements, as required by 21 CFR 820.50.
 
7.    Failure to establish and maintain procedures to ensure that mix-ups, damage, deterioration, contamination, or other adverse effects to product do not occur during handling as required by 21 CFR 820.140.
 
 
Medical Device Reporting
 
Our inspection also revealed that your firm’s device is 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 MDR procedures, as required by 21 CFR 803.17. For example, your firm has not developed the following:
 
1.    Internal systems that provide for:
a.    Timely and effective identification, communication, and evaluation of events that may be subject to medical device reporting requirements;
b.    A standardized review process/procedure for determining when an event meets the criteria for reporting under 21 CFR 803; and
c.    Timely transmission of complete medical device reports to FDA.
 
2.    Documentation and record-keeping requirements for:
a.    Information that was evaluated to determine if an event was reportable;
b.    All medical device reports and information submitted to FDA and manufacturers;
c.    Any information that was evaluated for the purpose of preparing the submission of annual reports; and
d.    Systems that ensure access to information that facilitates timely follow-up and inspection by FDA.
 
You confirmed during the inspection that you had not established MDR procedures and that you were unaware that you are required to do so.  
 
Quality, Purity, Strength
 
The inspection revealed that your devices are adulterated within the meaning of section 501(c) of the Act, 21 U.S.C. § 351(c) in that its strength differs from, or its purity, or quality falls below, that which it purports or is represented to possess.
 
Specifically, the lenses are labeled as “Sterile”; however you have no assurance of the sterility of the product, and our analysis of samples obtained from your buffers, water, saline, and manufacturing environment found microbial contamination including Pseudomonads putida, Bacillus bacteria, unidentified gram positive, unidentified gram negative bacteria, and mold. In addition, the lenses are labeled as containing 0.9% sodium chloride USP solution, buffered with sodium bicarbonate USP, but you manufacture the lenses with non-USP ingredients.
 
Use of Unsafe Colors
 
The inspection revealed that these devices are adulterated within the meaning of section 501(a)(4)(A) of the Act, 21 U.S.C. § 351(a)(4)(A) in that the dyes used for the purpose of coloring the contact lenses are unsafe within the meaning of section 721(a) of the Act.   Under the Act, the color additive and its use must conform to a listing regulation under Title 21 of the Code of Federal Regulations (CFR) Parts 73 and 74.
 
Specifically, you told our Investigator that you obtained the (b)(4) fabric dyes from (b)(4) Art Supply and you do not know if the dyes contain colors that are safe for use in contact lenses.  The manufacturer of the dyes labels and distributes the dyes for use in coloring textiles. Furthermore, our analysis of the following (b)(4) Dye samples found them to be unsafe for use in coloring contact lenses: (b)(4) Green Color Dye, (b)(4) Dye, (b)(4) Red Dye, (b)(4) Dye, (b)(4) Blue Dye, (b)(4) Green Dye, (b)(4) Black Dye, and (b)(4) Violet Dye.
 
Registration and Listing 
 
You are also required to submit annual registration for each establishment you own or operate that is engaged in the manufacture, preparation, propagation, compounding, or processing of a device under section 510(b)(2) of the Act, 21 U.S.C. § 360(b)(2). In addition, under section 510(j)(2) of the Act, 21 U.S.C. § 360(j)(2), you are required to annual report a list of each device you introduced for commercial distribution which has not been included in any list you previously filed with FDA, in addition to other information. You are required to submit annual registration and listing information during the period beginning October 1 and ending on December 31 [sections 510(b)(2) and (j)(2) of the Act]. Annual registration and listing information for fiscal year 2014 were required to be completed by December 3, 2013. Our records indicate that you have no yet fulfilled your annual registration and listing requirements for fiscal year 2014.
 
Therefore all of your firm’s devices are misbranded within the meaning of section 502(o) of the Act (21 U.S.C. § 352(0)), in that the devices were manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act (21 U.S.C. § 360) and were not included in a list required by section 510(j) of the Act (21 U.S.C. § 360(j)).
 
False and Misleading 
 
This inspection revealed that these devices are misbranded within the meaning of section 502(a), of the Act (21 U.S.C. § 352(a)), in that its labeling is false or misleading in any particular.  Specifically, the contact lenses are labeled as sterile, however laboratory analysis of environmental samples collected from water holding cooler and other solutions that come in direct contact with the lenses found microbial contamination such as, unidentified mold, Pseudomonas putida, Achromobacter denitrificans, Achromobacter xylosidans, Achromobactrum anthropic, Staphylococcus saprohyticus, Stenotrophomonas maltophilia, Ralstonia pickettii, unidentified Enterobacter spp., unidentified Staphylococcus spp, unidentified Bacillus spp, unidentified Achromobacter, unidentified gram positive rods, unidentified gram positive catalase negative rods, and unidentified gram positive pleiomeorphic coccobacilli. In addition, the contact lenses do not receive a bioburden reduction or sterilization treatment prior to distribution.
 
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 (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. Your firm’s response should be comprehensive and address all violations included in this Warning Letter.
 
Your firm’s response should be sent to: Lawton W. Lum, Director of Compliance at 1431 Harbor Bay Parkway, Alameda, CA 94502. Please refer to the Unique Identification Number 443368 when replying. If you have any questions about the contents of this letter, please contact: Sergio Chavez at (510) 337-6886 or (510) 337-6703 (fax).
 
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. 
 
 
Sincerely yours,
/S/                                                           
Kathleen M. Lewis, J.D.
Director, San Francisco District   

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