Mr. D. Mark Jordan
- Miami Fat Supply, Inc
1510 Max Hooks Road, #F
Groveland, FL 34736
- Issuing Office:
- Florida District Office
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
555 Winderley Place, Suite 200
Maitland, Florida 32751
VIA UPS NEXT DAY AIR
w/ DELIVERY CONFIRMATION
March 17, 2016
Donnell Mark Jordan
Miami Fat Supply, Inc.
1510 Max Hooks Road, Suite F
Groveland, FL 34736-8032 U.S.A.
Dear Mr. Jordan:
During an inspection of your firm located in Groveland, Florida on October 13, 2015 through October 14, 2015, an investigator from the United States Food and Drug Administration (FDA) determined that you are a manufacturer of the Red Head, Red Head 2, and the Jordy Connection System. 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 is intended to affect the structure or function of the body.
This inspection 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 requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820.
The violations include, but are not limited to, the following:
1) Failure to validate a process whose results cannot be fully verified by subsequent inspection and test according to established procedures, as required by 21 CFR 820.75(a). For example:
a) Your firm has not validated the (b)(4) sterilization cycle of (b)(4) that is provided as a recommended cycle for the (b)(4) sterilization processing of the Jordy Connection System, consisting of the Jordy cannula, adapters, and clip.
b) The (b)(4) and (b)(4) sterilization process validations failed to evaluate the Red Head 2 can withstand the rigors of multiple cleaning and (b)(4) sterilization processing. The Red Head 2 is promoted by your firm as “…a LIMITED use canister”. According to your firm’s representative, your firm informs users to inspect the canister and lid of the Red Head 2 for each reuse, including cleaning and sterilization processing, for visible stress or hairline cracks that may present a device failure.
2) Although not listed on the FDA Form 483, further review by Compliance Branch revealed a failure to establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met, as required by 21 CFR 820.30(a). For example, your firm has not conducted and/or documented design and development planning, design inputs, design outputs, design review, design verification, design validation, and/or design transfer activities for the Red Head 2, in accordance with your firm’s design control procedures, Document No. 4401, Revision E. Further, no design history file has been created or maintained for the Red Head 2.
3) Failure to establish and maintain procedures for the identification, documentation, validation or where appropriate verification, review, and approval of design changes before their implementation, as required by 21 CFR 820.30(i). For example, your firm has not implemented and recorded the design change of the Red Head 2 from gluing the funnel at the bottom of the canister to a non-glued, injection molded funnel shaped to the bottom of the canister, to address the structural stability of the canister after undergoing multiple (b)(4) sterilization cycles, in accordance with your firm’s design control procedures, Document No. 4401, Revision E. According to your firm’s representative, your firm does not maintain SOP 10200, as referenced in your firm’s design control procedure, or any other procedures for the implementation and control of design changes.
4) Failure to evaluate and select potential suppliers, contractors, and consultants on the basis of their ability to meet specified requirements, including quality requirements, as required by 21 CFR 820.50(a)(1). Specifically, your firm’s purchasing procedures, including Supplier Evaluation Form 400.0, fail to require that a supplier provide evidence of its capability to meet specified requirements. For example:
a) Your firm used (b)(4) as a supplier of lids, funnels, and Jordy adapters. However, according to your firm’s representative, no supplier evaluation had been conducted and documented for the evaluation and selection of (b)(4) as a supplier;
b) Your firm uses (b)(4) for the manufacture of lids, funnels, and Jordy adapters. However, the evaluation conducted for (b)(4), on October 7, 2015, does not include quality requirements to assure the manufacturer has been evaluated for its capability to perform processes such as Part Design, Prototyping, Mold Design, Mold Manufacturing, and Injection Molding.
5) Failure to document acceptance activities, as required by 21 CFR 820.80(e). For example, you do not document the results of final acceptance activities covering “Final Assembly”, including activities for canister gluing and leak testing. Your firm’s Red Head 1, Manifold, Fat Evacuation, Funnel Assembly Instructions, Form 601.0, Revision 0, states “The glued canister… is kept under (b)(4) for approx. (b)(4) insuring (sic) cure of the glue” and “…put the canister under (b)(4) pressure up to (b)(4) (sic) and hold for (b)(4) to make sure there are no (b)(4) leaks.” However, your firm maintains no documentation for final assembly acceptance inspection and testing for each batch of Red Head devices manufactured.
6) Failure to establish and maintain adequate procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a), and to ensure that all activities required under section 21 CFR 820.100 and their results are documented, as required by 21 CFR 820.100(b). For example:
a) Your firm’s Corrective and Preventive Action procedures fails to include provisions required under 21 CFR 820.100(a) including:
i) Identifying the action(s) needed to correct and prevent recurrence of non-conforming product and other quality problems, as required by 21 CFR 820.100(a)(3). Specifically:
(1) Your firm has become aware from complaints received, i.e., Complaint Record #6 and #13, that reuse of the Red Head 2, including multiple cleaning and sterilization processing, has been attributed to broken/cracked lids. According to your firm’s representative, your firm has elected to remove the Red Head 2 from the market until new lid material or mold can be made, but will continue to distribute the Red Head 2 devices to existing customers who have not filed a complaint.
(2) Complaint Record dated September 11, 2013 documents the Jordy Cannula plastic connection was warped and chipped on the side, actually melted. The record documents the results of the investigation as the device was not autoclaved properly, in that it was touching the metal tray and experienced excessive drying. No corrective action has been documented for the reported non-conformance.
ii) Analyzing processes, work operations, concessions, quality audit reports, quality records, service records, complaints, returned product, and other sources of quality data to identity existing and potential causes of nonconforming product, or other quality problems, as required by 21 CFR 820.100(a)(1).
iii) Verifying or validating the corrective and preventive action to ensure such action is effective and does not adversely affect the finished device, as required by 21 CFR 820.100(a)(4).
b) According to your firm’s representative, your firm does not maintain records, including the Corrective Action/Preventative Action Request Log, Form 1100.0; the Request Form – Corrective and Preventive Action (CAPA), Form 1101.0; and Corrective and Preventive Action (CAPA) Response Form, Form 1102.0, for documenting corrective and preventive action activities and their results.
7) 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. For example, your firm’s “Complaints File” procedures, established and maintain in your Quality Program, Revision 3, March 18, 2015, Section 12.0, do not include provisions to ensure that:
a) Complaints are processed in a uniform and timely manner;
b) Oral complaints are documented upon receipt;
c) Complaints to be evaluated to determine whether they represent events which must be reported to FDA under 21 CFR Part 803;
d) Complaints to be evaluated to determine whether an investigation is necessary, and when no investigation is made, to maintain a record as to why no investigation was made;
e) An investigation to be conducted for any complaint involving the possible failure of a device, labeling or packaging to meet its specifications; and
f) Complaints that meet the MDR reporting criteria are promptly reviewed, evaluated, and investigated by a designated individual, and maintained in a separate portion of the complaint files or otherwise clearly identified.
8) Failure to establish procedures for quality audits and conduct such audits to assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system, as required by 21 CFR 820.22. For example, your firm’s representative stated to the FDA investigator that your firm has not established and does not maintain procedures for the conduct of quality audits at defined intervals. Your firm has marketed the Red Head as of October 2011, the Read Head 2 as of January 2013, and the Jordy Connection System as of October 2013, but has not conducted internal quality audits.
This inspection also revealed that the Red Head, Red Head 2, and the Jordy Connection System 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 regarding the devices 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 deviations include, but are not limited to:
Failure to develop, maintain and implement written MDR procedures, as required by 21 CFR 803.17.
We have reviewed your October 28, 2015 response, concerning the investigator's observations noted on the Form FDA 483 (FDA 483), Inspectional Observations, which was issued to your firm. Your October 28, 2015 response did not provide adequate supporting evidence that the referenced corrections and planned courses of action have been implemented. We also acknowledge receipt of your response to the Form FDA 483, Inspectional Observations, dated February 23, 2016. We will evaluate the February 23, 2016 response along with any other written material provided as the direct response to this letter.
A review of our records reveals that your firm has not received premarket clearance or approval to market these devices in the United States, which is a violation of the law. Specifically, your devices’ Instructions for Use indicate that the Red Head, Red Head 2 and the Jordy Connection System consist of a powered suction pump, and consequently they are considered to be regulated under 21 CFR 878.5040 (Suction Lipoplasty System) Product Code MUU, Regulatory Class II, requiring a premarket clearance.
Therefore, the Red Head, Red Head 2, and the Jordy Connection System are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because you do 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 (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g). The Red Head, Red Head 2, and the Jordy Connection System are also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because you did not notify the agency of your intent to introduce the devices 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) of the Act, 21 U.S.C. § 360(k), is deemed satisfied when a PMA is pending before the agency, 21 CFR 807.81(b). The kind of information you need to submit in order to obtain approval or clearance for your device is described on the Internet at:
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 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 response should be sent to:
Salvatore N. Randazzo
555 Winderley Place, Suite 200
Maitland, Florida, 32751
Refer to the Unique CMS Identification Number 485740, when replying. If you have any questions about the content of this letter please contact: Salvatore N. Randazzo at (407) 475-4712.
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 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.
Susan M. Turcovski
Director, Florida District
Close Out Letter