Inspections, Compliance, Enforcement, and Criminal Investigations
Getinge/Castle, Inc. 24-Aug-01
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration
300 S. Riverside Plaza, Suite 550 South
Chicago, Illinois 60606
August 24, 2001
RETURN RECEIPT REQUESTED
Mr. Creighton White, President
1777 East Henrietta Road
Rochester, NY 14623-3133
Dear Mr. White:
During the inspection of the Arjo, Inc. facility in Roselle, IL, from April 16 to April 27, 2001, Investigator Matthew Sienko determined Arjo manufactures and distributes patient lifts and bath systems. Patient lifts and bath systems are devices as defined by Section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act).
The inspection revealed that these devices are adulterated within the meaning of Section501 (h) of the Act, in that the methods used in, or the facilities or controls used for manufacturing, packing, storage, or installation are not in conformance with the Quality System regulation for medical devices, as specified in Title 21, Code of Federal Regulations (CFR), Part 820, as follows:
1. Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints to ensure that all complaints are processed and documented in a uniform and timely manner. For example:
1.1. Arjo did not document complaints as required in their Product Complaint Procedure, QSP # 4.6.2, Section 6.2, dated October 14, 1999.
1.2. In 2001, 81 service calls were received complaining of transport problems with the Marisa lift. Arjo did not review, evaluate, or investigate these complaints. Arjo lacked documentation that explained why an investigation was not needed.
1.3. Arjo did not have a consistent and uniform system for categorizing complaints. Eleven complaints that were Medical Device Reports (MDR) were categorized as potential malfunctioning problems with the Maxilift but should have been categorized as sling products. Two MDR complaints lacked the product model name.
1.4. The following MDR complaints were not evaluated or investigated in a timely manner:
- MDR #9617021-2000-00052 has an initial report date of 6/7/00 and was not closed.
- MDR # 9617021-2000-00002 has an initial report date of 2/24/00 and was closed on 10/18/00.
- MDR #961702 1-2000-00118 has an initial report date of 1/3/00 and was closed on 10/25/00.
2. Failure to establish and maintain procedures for implementing corrective and preventive action that include requirements for analyzing complaints to identify existing and potential causes of nonconforming product. For example, Arjo did not perform trend analysis of complaints as required in their Product Complaint Procedure, QSP # 4.6.2, Section 6.4, dated October 14, 1999.
This letter is not intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to ensure adherence to each requirement of the Act and regulations. The specific violations noted in this letter and in the Form FDA-483 issued at the conclusion of the inspection may be symptomatic of serious underlying problems in your establishment?s quality system. You are responsible for investigating and determining the causes of the violations identified by the FDA. You also must promptly initiate permanent corrective and preventive action on your Quality System.
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, no premarket submissions for Class III devices to which the Quality System/GMP deficiencies are reasonably related will be cleared or approved until the violations have been corrected. Also, no requests for Certificates to Foreign Governments will be approved until the violations related to the subject devices have been corrected.
In order to facilitate FDA in making the determination that such corrections have been made, and thereby enabling FDA to withdraw its advisory to other federal agencies concerning the award of government contracts, and to resume marketing clearance for Class III devices for which a 510(k) premarket notification or Premarket Approval application (PMA) has been submitted, and resume approval for Certificates to Foreign Governments, we are requesting that you submit to this office on the schedule below, certification by an outside expert consultant that he/she has conducted an audit of your establishment?s manufacturing and quality assurance systems relative to the requirements of the device QS/GMP regulation(21 CFR Part 820). You should also submit a copy of the consultant?s report, and certification by your establishment?s Chief Executive Officer (if other than yourself) that he or she has reviewed the consultant?s report and that your establishment has initiated or completed all corrections called for in the report. The attached guidance may be helpful in selecting an appropriate consultant.
The initial certifications of audit and corrections and subsequent certifications of updated audits and corrections (if required) should be submitted to this office by the following dates:
Initial certifications by consultant and establishment: February 31, 2002
Subsequent certifications: February 31, 2003
We reviewed your firm?s response to our investigator?s FDA-483, in a letter dated May 17, 2001, from Mr. Ross Scavuzzo, President of Arjo, Inc. We determined the response is adequate. We also acknowledge receipt of documents provided by Mr. Scavuzzo and other Arjo representatives in a meeting with the Chicago District on August 1, 2001.
We request that you take prompt action to correct these deviations. Failure to promptly correct these deviations 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 penalties.
Please notify this office in writing, within 30 working days of receipt of this letter, of the specific steps you have taken to correct the noted violations, including an explanation of each step being taken to identify and make corrections to any underlying systems problems necessary to assure that similar violations will not recur. If corrective action cannot be completed within 30 working days, state the reason for the delay and the time within which the corrections will be completed.
Your response should be sent to Michael Lang, Compliance Officer. If you have any questions regarding this letter, please contact Mr. Lang at (312) 353-5863 xl71.Sincerely,
Raymond V. Mlecko