Inspections, Compliance, Enforcement, and Criminal Investigations
Berkline, LLC 21-Sep-06
Department of Health and Human Services
Public Health Service
New Orleans District
September 21, 2006
WARNING LETTER NO. 2006-NOL-16
Mr. Bill Whittenburg, President and CEO
One Berkline Drive
Morristown, TN 37813
Dear Mr. Whittenburg:
On July 24 - 31, 2006, a United States Food and Drug Administration (FDA) investigator inspected your firm, located at 214 Industrial Park Drive, Livingston, Tennessee. The investigation determined your firm manufactures automated lift chairs. 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 are intended to affect the structure or function of the body.
This inspection revealed these devices are adulterated within the meaning of Section 501(b) of the Act [21 USC, Section 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 (CGMP) requirements of the Quality System (QS) regulation found at Title 21, Code of Federal Regulations (CFR), Part 820. We received a response from John Vasquez, Vice President, Quality and Product Development, dated August 8, 2006, concerning our investigator's observations noted on the Form FDA 483, List of Inspectional Observations (483) issued to [redacted]. We address this response below, in relation to each of the noted violations. These violations include, but are not limited to, the following:
1. Failure to maintain proper management controls to ensure quality system requirements are met [21 CFR 820.20(a); 820.20(b)(3); 820.20(c); and, 820.20(e)]. For example, there is no representative of management or executive manager identified or responsible to ensure the automated lift chairs meet any quality standards. Neither management reviews nor quality systems specifically address device issues contained in the QS regulations.
We have reviewed your response and have concluded it is inadequate because you fail to state each specific step you will take to permanently correct the deviation. It is unclear as to management's understanding of this violation. No specific plan or procedure was provided, nor was a suitable timeframe for products currently being manufactured (483 items 1-5).
2. Failure to maintain written procedures to address, document, investigate, or implement corrective and preventive actions when quality issues arise or products fail [21 CFR 820.100(b)]. For example, no Corrective and Preventive Actions (CAPA) requirements are set in place for the automated lift chairs.
We have reviewed your response and have concluded it is inadequate because you failed to include specific information on how you will implement a CAPA system. No forms or examples were provided to ensure the firm's compliance with this QS requirement (483 item 6).
3. Failure to maintain written complaint handling systems specifically for the automated lift chairs [21CFR 820.198(a)(1); and, 820.198(a)]. For example, all of your complaints are handled in the same manner as for furniture. There is no exclusivity to devices included in consumer complaints, and there are inadequate follow-up investigations for product failures. There is no way to differentiate the automated lift chair complaints from the other complaints.
We have reviewed your response and have concluded it is inadequate because no specific information or investigation forms were provided to show compliance with this deviation. There is no explanation of how changes will affect the current complaint system, which covers furniture and devices with no differentiation (483 items 7-8).
4. Failure to analyze appropriate sources of quality data to identify existing and potential causes of non-conforming products and other quality problems [21 CFR 820.100(a)(1)]. For example, service reports and returned goods reports are not considered as sources of quality data. There are no proper investigations into product failures, which are commingled with consumer complaints about other furniture.
We have reviewed your response and have concluded it is inadequate because no specific information or data was provided to demonstrate your ability to properly address and correct this deviation (483 item 9).
5 . Failure to fully document rework and reevaluation activities in the device history record [21 CFR 820.40]. For example, you switch out parts of the lift chair device without documenting the rework. The final quality inspection of the device is to "ride" it. If the device is defective, it is replaced without investigation.
We have reviewed your response and have concluded it is inadequate because no evidence was presented to demonstrate this deviation will be corrected. No defect or rework logs, procedures, or investigations were provided as evidence of compliance with the QS regulations (483 item 10).
6. Failure to maintain and document control procedures specific to the automated lift chair (21 CFR 820.40). For example, reference materials are identified as Berkline, [redacted] and "Federal Department of Agriculture" (verbally identified as FDA manual). No procedures are specific to the manufacture of the auto4ated lift chair.
We have reviewed your response and have concluded it is inadequate because no procedure or evidence of this corrective action was provided for evaluation (483 item 11).
7. Failure to maintain written procedures or implement a system for reporting Medical Device Records (MDR) and to maintain written procedures (21 CFR 803.17). For example, your firm has no formal internal system to evaluate adverse events and submit the required MDR reports to FDA.
We have reviewed your response and have concluded it is inadequate because no procedure or documentation was provided for evaluation to determine if the corrective action has merit (483 item 12).
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 Food and Drug Administration 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 to which the QS regulation deviations 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 (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 Inspectional Observations, Form FDA 483, issued at the closeout 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. Kari L. Batey, Compliance Officer, at the address above. If you have any questions about the content of this letter please contact Ms. Kari L. Batey at (615) 781-5380, extension 112.
Carol S. Sanchez
Acting District Director
New Orleans District