Inspections, Compliance, Enforcement, and Criminal Investigations
YSIS, Incorporated 30-Nov-05
Department of Health and Human Services
Public Health Service
Cincinnati District Office
VIA FEDERAL EXPRESS
November 30, 2005
President and Chief Executive Officer
1725 Brannum Lane
Yellow Springs, OH 45387
Dear Mr. Omlor:
Between September 19 and October 4, 2005, the U.S. Food and Drug Administration (FDA) inspected your firm, YSIS, Inc. (YSIS), located at 2670 Indian Ripple Road, Dayton, Ohio. During the inspection, the FDA investigator observed that YSIS manufactures esophageal, rectal, and skin temperature probes. These are medical devices as defined in section 201(h) of the Federal,Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. § 321(h)).
This inspection revealed that these medical 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 manufacturing, packing, storage, or installation are not in conformance with the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation, as specified in Title 21, Code of Federal Regulations (C.F.R.), Part 820. Your firm's significant deviations from the QS regulation include, but are not limited to, the following:
Corrective and Preventive Actions
1. Failure to identify the actions needed to correct and prevent reoccurrence of nonconforming product and other quality problems, as required by 21 C.F.R.§820.100(a)(3). For example, your firm has not adequately identified the actions needed to correct and prevent an increase in total scrap for disposable temperature probes. In an initial attempt to correct the increase in total scrap, your firm implemented a training procedure for temporary employees. While the scrap level decreased during the first month after you implemented the procedure, it soon increased every month thereafter to an even higher level of scrap than what existed before you implemented the procedure. Despite this increase, your firm has not taken any further steps to identify the actions needed to correct and prevent the problem.
Production and Process Controls
2. Failure to establish and maintain procedures that address the identification, documentation, evaluation, segregation, and disposition of nonconforming product, and failure to document the evaluation and investigation of nonconforming product, as required by 21 C.F.R. § 820.90(a). For example, the FDA Investigator reviewed 31 device history records (DHR) that listed scrapped and/or reworked temperature probes. None of these nonconforming products were evaluated, and a determination of the need for an investigation and notification of the persons responsible for the nonconformance is not documented.
3. Failure to establish and maintain procedures for rework, including retesting and reevaluation of the nonconforming product after rework, to ensure the reworked product meets current approved specifications, and failure to document the rework and reevaluation activities in the DHR, as required by 21 C.F.R. § 820.90(b)(2). For example, the FDA Investigator's review of 17 DHRs revealed that 88 probes were reworked due to various nonconformances (such as failing leakage current testing, failing thermister resistance testing, and failing tip forming inspection). The retesting and reevaluation of this rework were not documented in the DHRs. Furthermore, the procedures used to control rework are not complete.
4. Failure to establish and maintain written procedures to control the design of the device inorder to ensure that specified design requirements are met, as required by 21 C.F.R.§ 820.30(a). For example, your firm's "Custom Product Development" procedure does not address design validation, design transfer, and the design history file (DHF).
5. Failure to establish and maintain procedures for the identification, documentation, validation or where appropriate verification, review, and approval of design changes, as required by 21 C.F.R. § 820.30(i). For example, 5 of the 13 Engineering Change Orders that the FDA investigator reviewed involved design changes to the temperature probes. Your firm did not document the reason for these changes, and it did not validate and verify them.
6. Failure to establish and maintain a DHF for each type of device that contains or references the records necessary to demonstrate that the design was developed in accordance with the approved design plan and the requirements of 21 C.F.R. Part 820, as required by 21 C.F.R. § 820.30(j). For example, your firm has not demonstrated that the design of the Disposable Temperature Probe [redacted] with a straight connector was developed in accordance with the approved design plan and the design control requirements of the QS regulation.
Moreover, the design controls for the Disposable Temperature Proboe [redacted] with a straight connector are inadequate because of deficiencies including, but not limited to, the following: (1) the design plan does not identify and describe interfaces with different groups or activities; (2) the design outputs that are essential for proper functioning of the probe are not identified; (3) the device has not been verified to show that the design output meets the design input requirements; (4) a formal document review of the design results has not been conducted and the results have not been documented; and (5) your firm has not established and maintained procedures to ensure that the device design is correctly translated into production specifications. See 21 C.F.R. §§ 820.30(b), (d), (e), (f), and (h).
7. Failure of management with executive responsibility to ensure that an effective quality system has been established and implemented, as required by 21 C.F.R. § 820.20. For example, your firm's quality system procedures for corrective and preventive action and
design change control are incomplete.
8. Failure to establish procedures for quality audits and to conduct such audits to assure that the QS is in compliance with the established QS requirements and to determine the effectiveness of the QS, as required by 21 C.F.R. § 820.22. For example, your firm's written audit procedure does not establish a set schedule for conducting quality audits. Additionally, the audit procedure does not specifically state what must be audited; instead, the items to be audited are determined by the auditor.
Please be aware that deviations described above are serious violations of the law that you must immediately correct. Failure to promptly correct these deviations may result in regulatory action being initiated by the FDA without further notice. Possible actions include, but are not limited to, seizure, injunction, and/or civil penalties.
This letter is not intended to be an all-inclusive list of deficiencies at your facility. The specific violations noted in this letter and in the List of Inspectional Observations (Form FDA 483), which was issued at the closeout of the inspection, may be symptomatic of serious underlying
problems in your firm's manufacturing and quality assurance systems. As the president and CEO of YSIS, it is your responsibility to ensure that your firm complies with each requirement of the Act and FDA regulations. Therefore, your firm should investigate and determine whether any other violations exist, and it must promptly correct any and all violations.
Federal agencies are advised of the issuance of all Warning Letters about medical devices so that they may take this information into account when considering the award of contracts. Additionally, no requests for Certifications to Foreign Governments will be approved until the violations related to the subject devices have been corrected.
Please notify this office, in writing, within fifteen (15) working days after you receive this letter, of the specific steps you have taken to correct these deficiencies. Furthermore, please submit any additional documentation to show that you have initiated corrections. If corrective action cannot be completed within fifteen (15) working days, state the reason for the delay and the timeframe within which the corrections will be completed.
Your written response to this Warning Letter should be sent to Ms. Gina Brackett, Compliance Officer, Food and Drug Administration, 6751 Steger Drive, Cincinnati, Ohio 45237. If you have any questions concerning the contents of this letter, you may contact Ms. Brackett at (513) 679-2700, extension 167, or you may forward a facsimile to her at (513) 679-2773.
Carol A. Heppe