Inspections, Compliance, Enforcement, and Criminal Investigations
Gyrus ACMI, Inc. 9/10/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|New England District|
One Montvale Avenue
Stoneham, Massachusetts 02180
FAX: (781) 587-7556
CMS # 353038
VIA UPS Next Day Air
September 10, 2012
Mr. Georg Schloer
Senior Vice President Operations
Olympus Gyrus ACMI, Inc.
136 Turnpike Road
Southborough, MA 01772
Dear Mr. Schloer:
During an inspection of your firm, Gyrus ACMI, Inc., located at 300 Stillwater Avenue, Stamford, CT on July 10 through August 2, 2012, investigators from the United States Food and Drug Administration (FDA) determined that your firm is a manufacturer of medical devices, including the DUR-D Ureteroscope. 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.
This 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.
We received a response dated August 22, 2012, from Terence E. Sullivan, Executive Director, Regulatory Affairs, Gyrus, ACMI, Inc. This was a response to the observations noted on Form FDA 483, List of Inspectional Observations that was issued to your facility at the close of our inspection. We do not consider your response adequate in addressing the investigator’s observations. We address your responses below, in relation to each of the noted violations. The violations include, but are not limited to, the following:
1. Failure to conduct design validation to ensure that the device conforms to defined user needs and intended uses and shall include testing of production units under actual or simulated use conditions, as required by 21 CFR 820.30(g). During the inspection, we observed that a FMEA dated January 2006 for your DUR-D ureteroscope noted that the device will be subject to bending and torque during normal use. It also identified kinking of as a potential problem and went on to state that a design review will verify flexible shaft performance. Your firm did not have any data to demonstrate the shaft was tested for bending and torque during actual use conditions to prevent kinking.
Your response to this observation is inadequate. You indicated that in 2010, your firm has made enhancements to your product development process. However, you have not provided documentation that this corrective action has been effective. In response to this Warning Letter, you should provide documentation that all design activities for the DUR-D ureteroscope are appropriate and complete.
2. Failure to establish and maintain procedures for receiving, reviewing and evaluating complaints to determine whether the complaint represents an event which is required to be reported to FDA under 21 CFR Part 803, Medical Device Reporting, as required by 21 CFR 820.198(a)(3). For example, your complaint procedure currently lacks detailed information as to the type of information required in order for your firm to be able to make an MDR assessment. For at least (b)(4) complaints reviewed during the inspection, we observed that there is no information in the complaint files to demonstrate that you contacted the complainant to collect additional information, as required by your current SOP.
Your response dated August 22, 2012 is inadequate. We are concerned by the amount of information being obtained for these complaints as well as the level of investigation being performed by your firm. You will need to provide us with your revised procedures, as well as employee training plans to assure that proposed corrective actions will prevent this violation from recurring.
Your response also notes that you will perform a retrospective review of a sample of complaints since January 2010. In response to this Warning Letter, you should provide documentation of these reviews and your plan for addressing any outstanding deficiencies that arise from this review.
You should take prompt action to correct the violation(s) addressed in this letter. Failure to promptly correct these violation(s) 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 violation(s), or similar violation(s), from occurring again. Include documentation of the corrective action 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.
Please direct your response or any questions you may have to Karen Archdeacon, Compliance Officer, Food and Drug Administration, One Montvale Avenue, 4th Floor, Stoneham, Massachusetts 02180. Her telephone number is (781) 587-7491.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violation(s) at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violation(s) 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 violation(s), and take prompt actions to correct the violation(s) and to bring your products into compliance.
Mutahar S. Shamsi
New England District
Mr. Hiroyuki Sasa
Shinjuku-ku Tokyo, Japan 163-0914
Mr. Frederick L. Wallach,
Director of Operations
Gyrus ACMI, Inc.
300 Stillwater Avenue
Stamford, CT 06902