Inspections, Compliance, Enforcement, and Criminal Investigations
InnoMed Technologies, Inc. and RespCare, Inc. 21-Feb-08
Department of Health and Human Services
Public Health Service
555 Winderley Pl., Ste. 200
RETURN RECEIPT REQUESTED
February 21, 2008
Sanjay Chandran, Chief Executive Officer
InnoMed Technologies, Inc.,
and RespCace, Inc.
6641 Lyons Road, Suite B1-B4
Coconut Creek, Florida 33073
Dear Mr. Chandran:
During an inspection of your firms located in Coconut Creek, Florida on September 19, 2007, through September 21, 2007, an investigator from the United States Food and Drug Administration (FDA) determined that your firms are specification developers and importers of various types of Class 11 continuous positive airway pressure (CPAP) interface devices used with currently marketed CPAP or bi-level positive pressure ventilation devices for treatment of respiratory insufficiencies and obstructive sleep apnea. 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. InnoMed and RespCare are two businesses at the same address operating under the same management. Both firms are registered with FDA under a single establishment registration and have jointly listed devices. During the inspection, firm management indicated that both firms use the same procedures for quality systems and adverse event reporting requirements.
This inspection revealed that your firms' 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 (CGMP) requirements of the Quality System (QS) regulation found at Title 21, Code of Federal Regulations, Part 820 (21 CFR 820). These violations include, but are not limited to, the following:
1. Failure to establish and maintain the requirements, including quality requirements, that must be met by suppliers, contractors, and consultants, as required by 21 CFR 820.50(a). For example;
a. The "Self Assessment Questionnaire" used by both firms does not establish the process validation requirements concerning molding/extrusion validation or mold/dye maintenance for contract manufacturers of tubing for each firm's devices.
b. The "Self Assessment Questionnaire," which is to provide the basis for your firms' evaluation of potential suppliers, consists solely of a series of questions answerable with "yes" or "no" and does not request any written evidence to substantiate the answers to these questions. Your procedures are thus not adequate to ensure that all purchased or otherwise received product and services conform to specified requirements and that you have evaluated and selected potential suppliers, contractors, and consultants on the basis of their ability to meet specified requirements, including quality requirements, as required by the regulations.
2. Failure to establish and maintain procedures adequate for implementing corrective and preventive actions (CAPA) that include verification or validation of such action, to ensure that the action is effective and does not adversely affect the finished devices, as required by 21 CFR 820.100(a)(4). For example;
a. The firms' CAPA procedures fail to require verification and/or validation to ensure that the CAPA is effective and will not adversely affect the finished device. The procedures also do not set forth how a CAPA will be assessed for effectiveness.
b. RespCare did not implement proper CAPA procedures, as evidenced by the following. RespCare received Complaint #07-024 dated O1/29/2007; and Complaint #07-032 dated 02/20/2007, alleging that Hybrid CPAP products had valves misassembled at your contract manufacturer in Taiwan. The files addressing investigations of these complaints indicate that RespCare concluded that action had already been taken in late October 2006, which would correct this. problem. However, there is no evidence that the October 2006 CAPA was verified and/or validated as an effective action. RespCare then received Complaint #07-085 dated 08/06/2007, which again alleged misassembly of a Hybrid valve. Your firm did not identify when this valve was manufactured although it was shipped from the manufacturer on 11/09/2006. Your firm received further proposed corrective action from its supplier on 08/13/2007; however, the firm does not have documentation that the 08/13/2007 corrective and preventive action (CAPA) was verified and/or validated.
3. Failure to perform testing on the design using production units under actual or simulated use conditions, and failure to document results of design validation as required by 21 CFR 820.30(g). For example, InnoMed received Complaint #06-050 dated 05/17/2006, in which the user states that the tubing from five Nasal Aire II products became stiff and uncomfortable after four to five months. Your firm stated that no investigation of the complaint was required because the device was used past its useful life. However, the Instructions for Use of these products do not indicate that the device or its tubing must be replaced every 3 months. Rather, they state that the device is to be cleaned after use, and may be cleaned at least 90 times: When speaking with the investigator, Mr. Collazo stated that the marketing people had decided that the device should be replaced every three months. In addition, Mr: Collazo stated that testing was done in August 2003, in which one Nasal Aire lI device was washed with detergent, disassembled and then reassembled 100 times; visually inspected and found to meet specifications; however, there was no documentation of this testing and Mr. Collazo stated that the firm has no documentation that identifies and substantiates the useful life of the product.
4. Failure to maintain a record that includes the reason that no investigation was made and the name of the individual responsible for the decision not to investigate, as required by 21 CFR 820.198(b). For example:
a. InnoMed received complaint #05-008 dated O1/19/2005, which references the Nasal PAP Freestyle product becoming brittle and Complaint #06-046 dated 05/10/2006, which references the Nasal Aire II product exhibiting an oily substance on its tubing. The firm has not documented the investigation or a reason for not investigating each of these complaints.
b. InnoMed received Complaint #06-021 dated 03/02/2006, and Complaint #06051 dated 05/24/2006, which reference kinked tubing in Nasal Aire devices. The firm has not documented the investigation or a reason for not investigating either of these complaints. While InnoMed provided the investigator with a 2004 Memo which states that they will not perform any, corrective actions on kinked tubing, this memo does not establish that no investigation was required to ensure that the kinking was a user issue and not possibly some defect in the tubing purchased from the supplier.
c. RespCare received Complaint #06-105 dated 09/26/2006, which references air leaking at elbow swivel of Hybrid CPAP product. The firm stated that no investigation was completed because the device had not been returned. The firm has not documented any further investigations for this complaint.
d. Mr. Burgos stated that neither InnoMed nor RespCare have any documentation of Complaint #05-029.
5. Failure to establish and conduct procedures for quality 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, the firms' written Internal Audit procedure does not address Corrective and Preventive Action, Medical Device Reporting, and Corrections and Removals.
Our inspection also revealed that Innomed's Nasal Aire II devices 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. 360i, and 21 C.F.R. Part 803 - Medical Device Reporting (MDR) regulation. For example, InnoMed received Complaint #05-043 dated 04/19/2005, which describes the development of a 15mm hole in the nasal septum of a patient using a Nasal Aire II product. There is no record of a MDR being submitted to FDA for this event. Under 21 CFR 803.50(a), a manufacturer must submit a MDR report within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a device marketed by the manufacturer may have caused or contributed to a serious injury.
You also have not developed, maintained, and implemented written MDR procedures as required under 21 CFR 803.17. Specifically, the only written procedure referring to MDR's that your firms provided during the inspection is the procedure entitled "Call Handling Procedure & Instructions for Filling Out Product Report Form." While this procedure and form address some of the questions relevant to determining whether a complaint constitutes a reportable MDR, this procedure does not ensure timely transmission of completed medical device reports to FDA as required by 21 CFR 803.17(a)(3) because, for example, it does not indicate where reports are to be sent and on what FDA forms (e.g., the 3500A and Baseline Reporting Form). The procedure also does not address documentation and recordkeeping requirements for MDRs as specified in 21 CFR 803.17(b).
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 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 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 actions you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. If corrective actions cannot be completed within fifteen (15) working days, state the reason for the delay and the time within which the corrections will be completed.
Your response should be sent to Matthew B. Thomaston, Compliance Officer, 555 Winderley Place, Suite.200, Maitland, Florida, 32751. If you have any questions about the content of this letter please contact Mr. Thomaston at (407) 475-4728.
Finally, you should know that 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 (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 to bring your products into compliance.
Emma R. Singleton
Director, Florida District