Soring Medical Technology 1/12/12
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
555 Winderley Place, Suite 200
Maitland, Florida 32751
RETURN RECEIPT REQUESTED
January 10, 2012
Soring Medical Technology
8000 NW 31st St, Suite 8
Doral, FL 33122
Dear Mr. Comacho:
During an inspection of your firm located in Doral FL on 11/17/2011 through 12/02/2011, an investigator (or investigators) from the United States Food and Drug Administration (FDA) determined that your firm is the initial distributor of a foreign entity (Soring GmbH Medizintechnik, headquartered in Quickborn, Germany) who manufactures Class II devices, and therefore is required to comply with 21 CFR 820 Quality System Regulations.
The inspection determined your firm distributes including but not limited to: the Sonoca-180 Ultrasonic assisted Wound Treatment (UAW); the Sonoca-185 Ultrasonic Assisted Wound Treatment (UAW); The Soring Ultrasonic Dissector Sonoca 300; Accessories for the Ultrasonic equipment such as Einmal- Cover Disposable Flue; Cold Plasma Coagulation Unit, and the high frequency Argon Plasma Coagulation. 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 are intended to affect the structure or function of the body.
Our inspection revealed that the devices you distribute 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 device that is required by or under section 519 of the Act, [21 U.S.C. § 360(i)], and Title 21, Code of Federal Regulations (CFR), Part 803 - Medical Device Reporting. These violations include, but are not limited to the following:
Failure to adequately develop, maintain, and implement written Medical Device Reporting (MDR) Procedures, as required by 21 CFR Part 803.17. For example, at the time of the inspection your firm failed to maintain written MDR procedures that provide for timely and effective identification, communication and evaluation of events that may be subject to MDR requirements.
We received a response from Mr. Nester O. Comacho dated December 13, 2011 concerning our investigator’s observations noted on the Form FDA 483 (FDA-483), List of Inspectional Observations, that was issued to your firm. We address this response below in relation to each of the noted violations. These violations include, but are not limited to the following:
Regarding your firm’s lack of MDR procedures, the adequacy of your firm’s response cannot be determined at this time because your firm failed to provide any documentation demonstrating the “procedures”, “diagramming”, and “forms” you state you are implementing.
Additionally, the 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.
1. Failure to establish and maintain adequate procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a). For example: Your firm has no written procedures for implementing and documenting corrective and preventive action including but not limited to:
a. Analyzing sources of quality data to identify existing and potential causes of quality problems.
b. Investigating the cause of the quality problems.
c. Identifying the action needed to correct and prevent recurrence of quality problems.
d. Verifying or validating the corrective and preventive action to ensure that such action is effective and does not adversely affect the finished device.
e. Implementing and recording changes in methods and procedures needed to correct and prevent identified quality problems.
f. Ensuring that information related to quality problems or nonconforming product is disseminated to those directly responsible for ensuring the quality of such product or the prevention of such problems.
2. 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: At the time of the inspection your firm had failed to establish and maintain complaint procedures which:
a. Ensure that each and every complaint received is documented upon receipt.
b. Ensure that all complaints are reviewed and evaluated to determine whether an investigation is necessary.
c. Ensure that if no investigation is conducted, the rationale and signature of the person making the determination is documented.
d. Ensure that when an investigation is conducted, the date of the complaint received is recorded and the dates and results of investigations are documented and retained as part of the complaint files.
e. Ensure that replies to the complainant are retained in the complaint records.
We note that your firm is utilizing (b)(4) for customer complaints, however these forms do not have a provision for recording if an investigation is necessary, if the complaint is MDR reportable, the dates and results of the investigation, or any corrective action taken and any reply to the complainant.
The adequacy of your firm’s response cannot be determined at this time. Although you stated in your response that you are in the process of implementing complaint procedures, we are unable to verify if your correction is adequate because you failed to submit any documentation such as a draft SOP or other documentation that verifies your correction.
3. Failure to establish quality system procedures and instructions, as required by 21 CFR 820.20(e). Your firm has no written procedures, including no written procedures which included an outline of the structure or documentation used in the quality system.
The adequacy of your firm’s response cannot be determined at this time due to a lack of detail and documentation outlining specifically how you will address the violation.
4. Failure to establish and maintain procedures adequate to control environmental conditions which could adversely effect product quality, as required by 21 CFR 820.70(c). Specifically, you fail to monitor or control environmental conditions for which you store your Soring Ultrasonic Dissector Sonoca 300 which has a temperature specification of 10 to 40 degrees C (~ 50 to 104 degrees F) and a relative humidity specification of 20% to 80%. The rooms in which this instrument is currently maintained fail to include calibrated temperature and humidity recording equipment.
Additionally, you store ultrasonic equipment such as (b)(4) – Cover Disposable Flue manufactured by Soring GmbH in Germany and shipped to your firm in bulk for storage in Miami FL. This instrument has a temperature specification of 50 to 85 degrees F and a relative humidity specification of 30 to 75%. The room currently used to store this instrument is neither temperature nor humidity controlled, nor monitored with calibrated equipment.
The adequacy of your firm’s response cannot be determined at this time. The room in use for storage of these devices has no temperature or humidity control nor any monitored calibrated equipment. Although you stated in your response that you are in the process of acquiring temperature and humidity control devices approved and calibrated by (b)(4) we are unable to verify if your correction is adequate because you failed to submit any documentation specifically addressing the purchasing, calibration and installation of these instruments.
5. Your firm’s personnel do not have the necessary training to perform their jobs, as required by 21 CFR 820.25(a). For example: Personnel at your firm were unaware of the Code of Federal Regulations, specifically 21 CFR sections 803 Medical Device Reporting and 820 Quality System Regulations which pertain to the activities performed at your firm located at Doral, FL.
The adequacy of your firm’s response cannot be determined at this time do to the lack of documentation you included such as completed training records to verify your written response that states all personnel will be properly instructed regarding the FDA regulations specifically 21 CFR Part 803 and 820.
6. Failure to establish and maintain adequate procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities as required by 21 CFR 820.25(b). For example: there were no procedures available for training or identifying training needs to ensure all personnel are trained to adequately perform their assigned duties.
Your response failed to include training roster’s or other documentation that indicates you have indeed begun training your employees; therefore we can not adequately verify your correction.
7. Failure to establish and maintain adequate procedures to control all documents, as required by 21 CFR 820.40. For example: Your firm has not established procedures for the control of documents including the date and signature of the approving personnel, controls for changes to documents or controls for obsolete documents.
Your response did not include any documentation such as draft SOP’s for document control, therefore, we cannot verify your corrective action.
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 (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: Florida District Office, 555 Winderley Place, Suite 200, Maitland Florida 32751. If you have any questions about the contents of this letter, please contact: Carla Norris at 407-475-4730.
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.
Emma R. Singleton
Director, Florida District