Inspections, Compliance, Enforcement, and Criminal Investigations
Kentron Health Care, Inc. 3/26/12
Department 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
March 26, 2012
WARNING LETTER NO. 2012-NOL-16
UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED
Nari T. Sadarangari, President/Owner
Kentron Health Care, Inc.
3604 Kelton Jackson Road
Springfield, Tennessee 37172-0120
Dear Dr. Sadarangari:
During an inspection of your firm, located at 3604 Kelton Jackson Road, Springfield, Tennessee, on October 5-7 and 11-12,2011, an investigator from the U.S. Food and Drug Administration (FDA) determined your firm manufactures non-surgical isolation gowns. Under Section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 United States Code (USC) 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 function of the body. You may find the specific regulations through links on FDA's Internet home page at http://www.fda.gov.
Our inspection revealed your devices are misbranded under Section 502(t)(2) of the Act [21 USC 352(t)(2)] as your firm failed or refused to furnish material or information regarding the devices, as required by Section 519 of the Act [21 USC 360(i)] and Title 21, Code of Federal Regulations, Part 803 (21 .CFR 803)- Medical Device Reporting (MDR). We received your response, dated October 26, 2011, concerning our investigator's observations noted on the October 12, 2011, FORM FDA 483, Inspectional Observations, (FDA 483) issued to you. Your responses are addressed below in relation to each of the noted violations. These 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(a). For example, after reviewing your firm's MDR Procedure, entitled Medical Device Reporting, dated September 10, 2010, the following issues were noted:
1. Your MDR procedure does not establish internal systems that provide for timely and effective identification, communication, and evaluation of events which may be subject to MDR requirements. For example, there are no definitions of what you consider a reportable event under 21 CFR Part 803. To facilitate the correct interpretation of reportable events and to assure the quality Omar submissions, the procedure should include definitions, based on 21 CFR 803.3, of the terms: "become aware," "caused or contributed," "malfunction," "MDR reportable event," and "serious injury;" as well as, definitions of the terms "reasonably known" and "reasonably suggests," found respectively in 21 CFR 803.50(b) and 21 CFR 803.20(c)(1).
2. Your MDR procedure does not establish internal systems that provide a standardized review process to determine when an event meets the criteria for reporting under 21 CFR Part 803.
a. Your procedure states the reporting of an event is determined by use of the complaint investigation form, which prompts the user to complete a MedWatch form, FDA Form 3500A. However, there are no instructions for conducting an investigation of each event and evaluating the cause of the event, as required by 21 CFR 803.50(b)(3).
b. The procedure does not specify who makes the decision for reporting events to FDA.
3. Your MDR procedure does not establish internal systems that provide for timely transmission of complete medical device reports. Specifically, the following are not addressed:
a. Instructions for how to obtain and complete the FDA Form 3500A;
b. Instructions for how you will submit all information reasonably known for each event;
c. Circumstances under which you must submit initial, supplemental, or follow-up reports and the requirements for such reports; and
d. The address for where to submit MDR reports: FDA, CDRH, Medical Device Reporting, P.O. Box 3002, Rockville, MD 20847-3002.
Your MDR procedure includes references to Baseline Reports. Baseline Reports are no longer required. We recommend all references to a Baseline Report be removed from your MDR procedure (see: 73 Federal Register Notice 53686, dated September 17, 2008).
If you wish to submit MDR reports electronically, follow the directions stated at the following URL: http://www.fda.gov/Forlndustry/FDAeSubmitter/ucm107903.htm
To discuss MDR reporting criteria or to schedule further communication, contact the MDR Policy Branch at 301-796-6670 or by email at MDRPolicy@fda.hhs.gov.
We reviewed your response and conclude it is not adequate. You stated "the MDR Procedures are being modified and corrected and will take between 90-120 days to implement." However you did not state what revisions will be made to the procedure or provide an updated version of the procedure for our review.
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. Federal agencies may be advised of the issuance of warning letters regarding devices so they may take this information into account when considering the award of contracts.
Please notify this office in writing within 15 business 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 recurring. Include documentation of the corrective actions you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. If corrective action cannot be completed within 15 business days, state the reason for the delay and the time within which the corrections will be completed. Your response should be comprehensive and address all violations included in this Warning Letter.
In addition, FDA noted nonconformities regarding Section 501(h) of the Act [21 USC 351(h)], which are deficiencies within your firm's quality system pertaining to Current Good Manufacturing Practice (CGMP) requirements specified in the Quality System (QS) regulation found at 21 CFR 820. These nonconformities include, but are not limited to, the following:
1. Failure to establish and maintain procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a). For example, your firm has no written corrective and preventive action procedures. In addition, your firm has failed to analyze quality data sources to identify existing and potential causes of nonconforming product, or other quality problems.
2. Failure to establish and maintain adequate 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, you changed the material weight specification of the isolation gowns from (b)(4) to (b)(4); however, you did not document the verification or, where appropriate, validation of this change before implementation. In addition, no documentation of this specification change was approved by firm management before implementation and manufacture of the device.
3. Failure to establish and maintain procedures to ensure all purchased or otherwise received product and services conform to specified requirements, as required by 21 CFR 820.50. For example, you have. not implemented purchasing controls to ensure devices are manufactured in accordance with established specifications including:
• Establishing written agreements with contract manufacturers and distributors to notify management of any changes in the product or services;
• Documenting the evaluation and selection of potential suppliers on the basis of their ability to meet specified requirements, including quality requirements;
• Defining the type and extent of control to be exercised over contractors and distributors based on evaluation results; and,
• Establishing and maintaining records of acceptable contractors.
4. Failure to establish and maintain procedures for acceptance of incoming product, as required by 21 CFR 820.80(b). For example, you failed to define, document, and implement receiving acceptance activities for incoming finished devices from contract manufacturers. There are no documented results of acceptance activities for product codes 920092, 920040, 923005, 923006, and 923007.
5. Failure to maintain adequate device master records, as required by 21 CFR 820.181. For example, the device master record for your isolation gown did not contain or reference the location of the gown specifications, production process specifications, quality assurance procedures and specifications, or packaging and labeling specifications. In addition, the material weight specification for the isolation gown, product code 920092, underwent a change in 2004 from (b)(4) to (b)(4); however, this specification change was not noted in the device master record.
6. Failure to establish and maintain procedures to ensure device history records for each batch, lot, or unit are maintained to demonstrate the device is manufactured in accordance with the device master record and the requirements of 21 CFR 820, as required by 21 CFR 820.184. For example, you have not maintained a device history record for each batch, lot, or unit manufactured.
7. Failure to establish and maintain procedures for quality audits and to conduct such audits to assure your 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, you have not established quality audit procedures, nor have you performed quality audits.
We reviewed your responses to items 1-7 above and conclude they are not adequate. Although you stated you would create or modify and implement applicable procedures within 90-120 days, it is not clear whether you determined the cause for not having established procedures or how you would ensure they are completed. Furthermore, it is unclear whether you identified, or would identify, the actions needed to ensure similar quality problems do not occur.
Your response should be sent to: Rebecca A. Asente, Compliance Officer, at the address above. If you have any questions about the content of this letter, please contact: Ms. Asente at (504) 832-1290, extension 1104.
Finally, this letter is not intended to be an all-inclusive list of 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 conclusion 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 action to correct the violations and to bring your products into compliance.
Patricia K. Schafer
New Orleans District Office
Enclosure: FDA 483, dated October 12, 2011