• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

  • Print
  • Share
  • E-mail

Airsep Corporation 9/15/08

   

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

Public Health Service
Food and Drug Administration
  New York District
158-15 Liberty Avenue
Jamaica, NY 11433466 


September 15,2008


WARNING LETTER


Ref.: NYK 2008-18

FEDERAL EXPRESS


Mr. Ravi Bansal, Chairman and CEO
AirSep Corporation.
401 Creekside Drive
Buffalo, NY 14228-2085

Dear Mr. Bansal:

During an inspection of your firm located at 401 Creekside Drive, Buffalo, NY from June 6, 2008 through June 19,2008, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures portable oxygen generators for respiratory therapy. 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 far use in the diagnosis, cure,mitigation; treatment, or prevention of disease, or are intended to affect the structure or any function of the body.

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 (CGMP) requirements of the Quality System (QS) regulation found at Title 21, Code of Federal Regulations (C.F.R.), Part 820. The inspection also revealed that these devices are misbranded within the meaning of section 502(t)(2) of the Act, 21 U.S.C. 352(t)(2), in that your firm failed or refused to furnish material information respecting these devices that is required under section 519 of the Act, 21 U.S.C. 360i, and 21 CFR Part 803, the Medical Device Reporting (MDR) regulation.

At the conclusion of the inspection, our investigator issued a Form FDA 483, List of Inspectional Observations, to Joseph L. Priest, President and COO (copy enclosed). We received a response from Peter L. Weisenborn, Vice President of Resources & Regulatory Affairs, dated June 26, 2008, to our investigator's observations noted on the Form FDA 483, List of Inspectional Observations, that was issued to Mr. Priest. We address these responses below, in relation to each of the noted violations.

The violations noted during our inspection include, but are not limited to, the following:

1. 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(a). In order to comply with this requirement, such procedures must ensure that: (1) all complaints are processed in a uniform and timely manner; (2) oral complaints are documented upon receipt; and (3) complaints are evaluated to determine whether the complaint represents an event which is required to be reported to FDA under 21 CFR Part 803, Medical Device Reporting.

Your firm's procedure, "Processing of Customer Complaints," document number QAMP-505, Rev. B (effective February 1, 2005), does not provide adequate procedures for receiving, reviewing, and/or evaluating complaints when a device is not returned. Your firm's procedure provides, "[i]n cases where the device is not returned, Quality Assurance and/or the Manager of Regulatory affairs may conduct an appropriate investigation" (emphasis added). Complaints must be processed and evaluated regardless of whether or not the device has been returned to your firm, in order to comply with 21 CFR § 820.198(a).

Your firm's procedure also fails to comply with 21 CFR § 820.l98(a), in that it does not provide: adequate procedures to ensure that complaints are processed in a uniform and timely manner. Your firm's procedure does not provide any instruction or limitation as to how long an investigation should take. It only mentions that the Customer Liaison receiving the complaint should route the complaint form to the QA department in a timely manner. After that, there doesn't appear to be any mechanism in place to assure that these complaints are being actively investigated.

In addition, your firm's procedure also fails to comply with 21 CFR § 820. 198(a), in that it does not ensure complaints are evaluated to determine whether the complaint represents an event which is required to be reported to FDA under 21 CFR Part 803, Medical Device Reporting. Specifically, your firm's procedure does not ensure that complaints involving unreturned devices are evaluated to determine whether the complaint is an MDR event. Your firm's procedure states that with respect to complaints involving unreturned devices the Quality Assurance and/or the Manager of Regulatory affairs may conduct an appropriate investigation. Complaints CC08D-04, dated April 21 , 2008, involving AirSep NewLife Elite Oxygen Concentrator with serial number 716012 and CC05I-83, dated September 29, 2005 concerned an AirSep NewLife Elite Oxygen Concentrator with serial number 206903, both involved patient deaths where the units were not returned, and there is no documentation as to whether or not the complaints were evaluated to determine whether an MDR should be filed. However, the complaint must be evaluated for possible MDR reporting regardless of whether or not the units are returned to comply with 21 CFR § 820.198.

In his June 26, 2008, written response, Mr. Weisenborn states that "[c]omplaint handling procedures will be revised to include the investigation of devices not returned to AirSep Corporation." This response is inadequate. Your procedure must ensure that all complaints are processed in a timely and uniform manner and that all complaints are evaluated to determine whether an MDR must be filed Please submit a copy of the revised document as part of your response to this letter for our review and a determination of its adequacy.

2. Failure to review and evaluate all complaints to determine whether an investigation is necessary, as required by 21 CFR 820.198(b). Based on the information gathered during the inspection, your firm did not review and evaluate the following complaints:

a) Customer Complaint CC08D-04, dated April 21, 2008, involving AirSep NewLife Elite Oxygen Concentrator with serial number 716012;
b) Customer Complaint CC07J-01, dated October 18, 2007, involving AirSep NewLife Oxygen Concentrator with serial number 186369; and
c) Customer Complaint CC05I-83, dated September 29,2005 concerned an AirSep NewLife Elite Oxygen Concentrator with serial number 206903.

In addition, 21 CFR § 802.l98(b) requires that when no investigation is made of the complaint, the manufacturer is required to maintain a record that includes the reason no investigation was made and the name of the individual responsible for the decision not to investigate. Our inspection, however, did not find any such record for the complaints listed above.

In his June 26, 2008, written response, Mr. Weisenborn states that "[a] review of open complaints will be done periodically, not longer than 30 days depending on nature of complaint. This has been corrected." This response is inadequate. Your evaluation must be completed within 30 calendar days regardless of the nature of the complaint. As discussed below, 21 CFR 803.50(a)(1) states that a manufacturer must report no later than 30 calendar days after the day it receives or otherwise becomes aware of information, from any source, that reasonably suggests that a device it markets may have caused or contributed to a death or serious injury.

3. Failure to review, evaluate, and investigate complaints involving the possible failure of a device, labeling, or packaging to meet any of its specifications, as required by 21 CFR § 820.198(c). For example, your firm did not review, evaluate, and investigate:

a) Customer Complaint CC07J-01, dated October 18, 2007, concerned an AirSep NewLife Oxygen Concentrator, serial number 186369, and was reportedly associated with a claim of fire damage caused by the device;
b) Customer Complaint CC051-83, dated September 29, 2005 concerned an AirSep NewLife Elite Oxygen Concentrator, serial number 206903, and was reportedly associated with a patient death; and
c) Customer Complaint CC08D-04, dated April 21, 2008, involved a patient death while using an AirSep NewLife Elite Oxygen Concentrator, serial number 716012.

4. Failure to promptly review, evaluate, and investigate, by a designated individual, and maintain in a separate portion of the complaint file those complaints that represent an event which must be reported to FDA under 21 CFR § 803, as required by 21 CFR § 820.198(d).
For example, your firm did not have a designated individual promptly review, evaluate, and investigate the following complaints:

a) Customer Complaint CC08D-04, dated April. 21, 2008, involved a patient death while using an AirSep NewLife Elite Oxygen Concentrator, serial number 716012;
b) Customer Complaint CC05l-83, dated September 29, 2005, involved a patient death while using an AirSep NewLife Elite Oxygen Concentrator, serial number 206903;
and
c) Customer Complaint CC07J-Ol, dated October 18, 2007, concerned an AirSep NewLife Oxygen Concentrator, serial number 186369, and was reportedly associated with a claim of fire damage caused by the device.

In addition, your firm is required to maintain records of the investigation to include a determination of(1) whether the device failed to meet specifications, (2) whether the device was being used for treatment or diagnosis, and (3) the relationship, if any, of the device to the reported incident or adverse event, to comply with 21 CFR § 820.198(d).

The inspection revealed that since 2004, there have been (b)(4) complaints concerning your oxygen concentrators. It is requested that you conduct an investigation into each of these complaints to determine if there are any trends relative to the servicing and maintenance of these devices. Your investigation should include a review of all service and maintenance records to determine if there are any trends in component failures or replacement. We request that you please provide a report of your findings to this office as part of your overall response to this letter.

5. Failure to submit an MDR within 30 days of receiving or otherwise becoming aware of information that reasonably suggested that a marketed device may have caused or contributed to a death or serious injury, as required by 21 CFR 803.50(a)(1). Specifically,
MDRs were not submitted for the following complaints:

a) Customer Complaint CC08D-04 dated April 21, 2008. The complainant reported a patient death due to fire, while using AirSep NewLife Elite Oxygen Concentrator, serial number 716012;
b) Customer Complaint CC06G-OI dated July 27, 2006. The complainant reported a patient death due to a fire of unknown cause. The complaint form reports an AirSep NewLife Oxygen Concentrator, serial number unknown, may have been located at or near the origin of the fire;
c) Customer Complaint CC060A-05 dated January 27,2006. The complainant reported a patient death due to fire while using AirSep NewLife Oxygen Concentrator, serial number 527332;
d) Customer Complaint CC05I-83 dated September 29, 2005. The complainant reported a patient death due to a fire of unknown cause. AirSep NewLife Elite Oxygen Concentrator, serial number 206903 was in the patient's bedroom at the time; and
e) Customer Complaint CC04A-53 dated January 9,2004. The complainant reported suffering severe facial bums due to fire while using AirSep NewLife Elite Oxygen Concentrator, serial number 369381.

In his June 26,2008, written response to the 483 observations, Mr. Weisenborn stated that, "[f]uture MDR Reports will be filed or justified for not being filed within 30 days of a reported incident" (emphasis added). This response is inadequate. Your firm is required to submit an MDR "no later than 30 calendar days after the day that you receive or otherwise become aware of information, from any source, that reasonably suggests that a device you market ... [m]ay have caused or contributed to a death or serious injury" to comply with 21 CFR 803.50(a). The regulation does not provide for any exceptions. Therefore, the MDR reporting requirement may not be 'justified for not being filed within 30 days of a reported incident. " Mr. Weisenborn also stated in his written response that "past incidents will have MD Reports submitted for examples noted" in the 483. Please inform us in your response to this letter if this has been accomplished.

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 applicaitons for Class III devices to which the Quality System regulation deviations are reasonably related will not be approved until the violations related to the subject devices 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 any 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 working days, state the reason for the delay and the time within which the corrections will be completed. Your response should be directed to Richard T. Trainor, Compliance Officer, U.S. Food and Drug Administration, 300 Hamilton Ave., White Plains, York 10601, telephone 914-682-6166 x34.

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 Observation, 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 and to bring your products into compliance.

Sincerely, 

/s/
Otto D. Vitillo
District Director


Enclosure


cc: Joseph 1. Priest, President and COO
(same address)