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U.S. Department of Health and Human Services

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Enforcement Actions

Amplion Clinical Communications Inc 12/17/13

  

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

Public Health Service
Food and Drug Administration
 
New Orleans District
404 BNA Drive
Building 200 – Suite 500
Nashville, TN 37217
Telephone: (615) 366-7801
          FAX: (615) 366-7802

 

December 17, 2013
 
WARNING LETTER NO. 2014-NOL-07
  
UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED
 
Thomas M. Stephenson, President/CEO
Amplion Clinical Communications, Inc.
632 Melrose Avenue
Nashville, Tennessee 37211
 
Dear Mr. Stephenson:
 
On October 28 -30, and November 4, 2013, a United States Food and Drug Administration (FDA) investigator inspected your firm, located at 632 Melrose Avenue, Nashville, Tennessee. The inspection determined your firm is operating as a manufacturer of a Class II medical device called Amplion Alert System, which includes both computer hardware and software functions. Under Section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 United States Code (USC) 321(h), this product is a device because it is 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.
 
This inspection revealed this device is adulterated within the meaning of Section 501(h) of the Act [21 USC 351(h)], because 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.  We received your firm’s response to the Form FDA 483 (FDA 483) on November 22, 2013, and our evaluation of your response is discussed below. Violations revealed during the inspection include, but are not limited to, the following:
 
1.   Failure to establish procedures for quality audits and conduct such audits to assure 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. Specifically, your procedure addressing quality audits has not been implemented. Additionally, your firm has not performed quality audits of your facility and suppliers.
 
We reviewed your response to the FDA 483 received on November 22, 2013. The procedure appears adequate. We will verify the implementation of this procedure during our next inspection of your firm. 
 
2.   Failure to implement procedures to ensure all purchased or otherwise received product conform to specified requirements, as required by 21 CFR 820.50. Specifically, your firm’s purchasing control procedures were in draft form and you failed to maintain records of acceptable suppliers.
 
We reviewed your response to the FDA 483 received on November 22, 2013. You provided a blank vendor survey; however, you have not provided evidence your firm has met the full requirements of 21 CFR 820.50, which includes:
 
(a)       Evaluation of suppliers, contractors, and consultants. Each manufacturer shall establish and maintain the requirements, including quality requirements, which must be met by suppliers, contractors, and consultants. Each manufacturer shall:
 
(1)      Evaluate and select potential suppliers, contractors, and consultants, on the basis of their ability to meet specified requirements, including quality requirements. The evaluation shall be documented. 
(2)      Define the type and extent of control to be exercised over the product, services, suppliers, contractors, and consultants, based on the evaluation results.
(3)      Establish and maintain records of acceptable suppliers, contractors, and consultants.
 
(b)      Purchasing data. Each manufacturer shall establish and maintain data that clearly describe or reference the specified requirements, including quality requirements, for purchased or otherwise received product and services. Purchasing documents shall include, where possible, an agreement the suppliers, contractors, and consultants agree to notify the manufacturer of changes in the product or service so that manufacturers may determine whether the changes may affect the quality of a finished device. Purchasing data shall be approved in accordance with 21 CFR 820.40.
 
3.   Failure to establish and maintain adequate procedures to control the design of the device in order to ensure specified design requirements are met, as required by 21 CFR 820.30(a)(1). Specifically, your firm failed to define, document, and implement procedures to control the design process, including requirements for design inputs; design outputs; design reviews; design verification/validations; design transfer; and design changes for your Amplion Alert System device.
 
We reviewed your response to the FDA 483 received on November 22, 2013. You provided a template for the “(b)(4);” however, you have not provided evidence your firm has met the full requirements of 21 CFR 820.30.
 
4.   Failure to establish procedures for corrective and preventive action (CAPA), as required by 21 CFR 820.100(a). For example, your firm failed to establish procedures for the following requirements:
 
a.    Analyzing processes, work operations, concessions, quality audit reports, quality records, service records, complaints, returned product, and other sources of quality data to identify existing and potential causes of nonconforming product, or other quality problems;
b.    Investigating the cause of nonconformities relating to product, processes, and the quality system;
c.    Identifying the action(s) needed to correct and prevent recurrence of nonconforming product and other quality problems;
d.    Verifying or validating the CAPA to ensure 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 information related to quality problems or nonconforming product is disseminated to those directly responsible for assuring the quality of such product or the prevention of such problems; and,
g.    Submitting relevant information on identified quality problems, as well as CAPAs, for management review.
 
We reviewed your response to the FDA 483 received on November 22, 2013.  You provided a template for the CAPA form and work instruction on how to fill out the form; however, you have not provided evidence your firm has met the full requirements of 21 CFR 820.100.
 
5.   Failure to establish and maintain a Design History File (DHF) for each type of device to demonstrate the design was developed in accordance with the approved design plan and  design control requirements, as required by 21 CFR 820.30(j). For example, your firm failed to establish a DHF for your Amplion Alert System device to demonstrate the device was developed in accordance with an approved design plan. Additionally, your firm failed to maintain documentation for the development of the device at your firm, pursuant to 21 CFR 820.30(j).
 
We reviewed your response to the FDA 483 received on November 22, 2013. Your response indicates you will have the DHF established by April 30, 2014; however, you have not provided evidence your firm has met the full requirements of 21 CFR 820.30(j).
 
6. Failure to maintain Device Master Records (DMRs) for your Amplion Alert System device, as required by 21 CFR 820.181. For example, your firm has not documented, or referenced the location of, the following required information for the device you manufacture:
 
a.   Device specifications;
b.   Production process specifications;
c.   Quality assurance procedures and specifications; and,
d.   Packaging and labeling specifications.
 
We reviewed your response to the FDA 483 received on November 22, 2013. Your response indicates you will have the DMR established by April 30, 2014; however, you have not provided evidence your firm has met the full requirements of 21 CFR 820.181.
 
7.   Failure to establish and maintain adequate procedures to ensure Device History Records (DHRs) for each batch, lot, or unit are maintained to demonstrate the device is manufactured  in accordance with the DMR, as required by 21 CFR 820.184. For example, your firm failed to define, document, and implement written procedures for maintaining DHRs. Additionally, your firm does not maintain DHRs for the manufacture of the Amplion Alert System device.
 
We reviewed your response to the FDA 483 received on November 22, 2013. Your response indicates the device history record has been established. The record appears adequate. We will evaluate the DHRs during our next inspection of your firm. 
 
8. Failure of management with executive responsibility to review the suitability of the quality system at defined intervals and with sufficient frequency according to established procedures to ensure the quality system satisfies the requirements of this part, as required by 21 CFR 820.20(c). For example, your firm failed to conduct management review meetings during the life of the Amplion Alert System device from February 8, 2010, to present.
 
We reviewed your response to the FDA 483 received on November 22, 2013. Your response indicates the Management Review process will be established by February 7, 2014; however, you have not provided evidence your firm has met the full requirements of 21 CFR 820.20(c). 
 
9. Failure to establish and maintain procedures to control product that does not conform to specified requirements, as required by 21 CFR 820.90. Specifically, procedures have not been defined, documented, or implemented to control product that does not conform to specified requirements. Additionally, your firm has not documented non-conforming product.
 
We reviewed your response to the FDA 483 received on November 22, 2013. Your response indicates the procedures for controlling product which does not conform to specified requirements will be established by January 31, 2014; however, you have not provided evidence your firm has met the full requirements of 21 CFR 820.90.
 
10. Failure to establish and maintain procedures for acceptance activities, which include: inspections, tests, or other verification activities, as required by 21 CFR 820.80. Specifically, your firm failed to define, document, or implement procedures for acceptance activities including receiving, in-process, and final acceptance activities.
 
We reviewed your response to the FDA 483 received on November 22, 2013. You provided blank templates for the “(b)(4)” and “(b)(4)” however, you have not provided evidence your firm has met the full requirements of 21 CFR 820.80.
 
11. Failure to establish and maintain procedures to control all documents, as required by 21 CFR 820.40. Specifically, your firm failed to define, document, and implement document control procedures.
 
We reviewed your response to the FDA 483 received on November 22, 2013. The procedure appears adequate. We will verify the implementation of this procedure during our next inspection of your firm.
 
Additionally, your firm’s device is also misbranded under Section 502(t)(2) of the Act [21 USC 352(t)(2)] because your firm failed or refused to furnish material or information respecting the device which is required by or under Section 519 of the Act [21 USC 360i] and 21 CFR 803 - Medical Device Reporting (MDR).  Specifically, your firm failed to develop, maintain, and implement written MDR procedures, as required by 21 CFR 803.17. 
 
We reviewed your response to the FDA 483 received on November 22, 2013. The procedure appears adequate. We will verify the implementation of this procedure during our next inspection of your firm.
 
You 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/or civil money penalties. Also, Federal agencies are advised of the issuance of all warning letters about devices so they may take this information into account when considering the award of contracts. Additionally, premarket approval applications for Class III devices 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 15 working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again.  Include documentation of the corrective action you have taken.  If your planned correction will occur over time, please include a timetable for implementation of those corrections.  If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.
 
Finally, you should know this letter is not intended to be an all-inclusive list of the violations at your facility.  It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA.  The specific violations noted in this letter and in the FDA 483, issued at the close out of the inspection, may be symptomatic of serious problems in your firm's manufacturing and quality assurance systems.  You should investigate and determine the causes of the violations, and take prompt actions to correct the violations and to bring your products into compliance.
 
 
Your response should be sent to: Ms. Kimberly Dutzek, Compliance Officer, at the address above. If you have any questions about the content of this letter please contact Ms. Dutzek at (615) 366-7826.
 
Sincerely,
/S/ 
Patricia Schafer
District Director
New Orleans District
 
 
cc:   
David L. Condra, COO
Amplion Clinical Communications, Inc.
632 Melrose Avenue
Nashville, Tennessee 37211