Inspections, Compliance, Enforcement, and Criminal Investigations
Gaymar Industries, Inc. 08-Jun-06
Department of Health and Human Services
Public Health Service
New York District
RETURN RECEIPT REQUESTED
June 8, 2006
Thomas P. Stewart
President & Chief Operating Officer
Gaymar Industries, Inc.
10 Centre Drive
Orchard Park, NY 14127
Dear Mr. Stewart:
During an inspection of your establishment located in Orchard Park, New York on January 18, 2006 through February 15, 2006 and March 10, 2006 through March 13, 2006, our investigator determined that your establishment manufactures the Medi-Temp III Blood & Fluid Warmer, which is a device as defined by Section 201(h) [21U.S.C. 321(h)] of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 321 et seq.]. The inspection revealed that these blood/fluid warmers are misbranded and adulterated under the Act, as described below.
Since obtaining ownership of the Dupaco Counter Flo 300 Blood/Fluid Warmer in 1997, your firm has manufactured several versions of the device, including the Medi-Temp Blood & Fluid Warmer, versions FW300, FW400, and FW600. A review of our records revealed that no premarket clearance (510(k)) submission has been received by the Center for Biologics Evaluation and Research (CBER) for the changes made to the Medi-Temp Blood & Fluid Warmer, versions FW400 and FW600. These devices are therefore misbranded under section 502(o) of the Act [21 U.S.C. 352(o)], in that a notice or other information respecting the devices was not provided to FDA as required by section 510(k) of the Act. The devices are also adulterated under section 501(f)(1)(B) of the Act [21 U.S.C. 351(f)(1)(B)] for failure to obtain FDA premarket approval. (For a product requiring premarket approval before marketing, the notification required by section 510(k) of the Act is deemed to be satisfied when a premarket approval application (PMA) is pending before the Agency. Title 21, Code of Federal Regulations (21 CFR) 807.81(b)).
The investigator also documented violations of the Act causing the device to be adulterated within the meaning of Section 541(h) [21U.S.C . 351(h)], in that the methods used in, or the facilities or controls used for manufacturing, packing, storage, or installation are not in conformance with current Good Manufacturing Practice (cGMP) requirements of the Quality System (QS) Regulation for medical devices, as specified in 21CFR Part 820.
Significant deviations observed during the inspection included, but are not limited to, the following:
1 . Failure to implement and record changes in methods and procedures needed to correct and prevent identified quality problems [21 CFR 820.100(a)(5)] and to record any corrective action taken during investigation of a complaint [21 CFR 820.198(e)(7)]. Specifically, manufacturing/assembly procedures, device history records, and complaint investigation records do not document specification changes and corrective actions to at least eight Medi-Temp III Blood & Fluid Warmers, version FW600, under Engineering Order # 2004034. The devices were returned to your firm in 2005 for complaint investigation or repair to correct reports of overheating or failure.
2. Failure to include in the Device Master Record, or refer to the location of, all device specifications, production process specifications, and quality assurance procedures [21 CFR 820.181]. Specifically, your Device Master Record (DMR) was last dated and signed on June 19, 2002, but your firm implemented a design change to the front panel label adhesive of the Medi-Temp III (FW600) in March 2004. There was no documentation of this design change in the Device Master Record.
3. Failure to establish and maintain data that clearly describe or reference the specified requirements, including quality requirements, for purchased or otherwise received product and services [21 CFR 820.50(b)] and procedures to document that incoming product has been inspected, tested, or otherwise verified as conforming to specified requirements [21CFR 820.80(b)]. Specifically, your firm used an identical part number (#11288) to identify both the original front panel label for the Medi-Temp III Blood & Fluid Warmer and the revised interim front panel label, described in Engineering Order #2004034, although the adhesive material and specifications were different. The interim front panel label, implemented in March 2004, was designated for use for a few months, until your vendor could supply the requested [redacted] Foam Tape [redacted] adhesive. However, in May 2005, during an investigation into a device malfunction, your firm discovered that the interim front panel label was still in use.
The above violations are not intended to be an all inclusive list of deficiencies at your facility. It is your responsibility to ensure that your establishment is in compliance with all requirements of applicable FDA 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 must also promptly initiate permanent corrective and preventive action on your Quality System.
You should take prompt action to correct these deviations. Failure to promptly correct these deviations may result in regulatory action without further notice. Federal agencies are advised of the issuance of all Warning Letters about drugs and devices so that they may take this information into account when considering the award of contracts. Additionally, no premarket approval applications for Class III devices to which the Quality System/GMP deficiencies are reasonably related will be 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 device have been corrected.
We have reviewed your response letters dated March 3, and March 24, 2006 responding to the inspectional observations on the Form FDA 483 issued on February 15, 2006. Your responses were found to be inadequate to address our concerns described above. Our comments to your responses follow.
1. We acknowledge your general commitment to correct the deviations identified during the inspection. However, sufficient detail concerning the implementation of the proposed corrections was not provided. In addition, the responses fail to address the root cause of the observations and the methods your firm will use to determine the effectiveness of the corrective actions. For example:
a. In your March 24, 2006 response, you stated that SOP-1500 Rev. B (Device Master Record) has been revised to clarify Quality System Regulation requirements. Please provide a copy of this Standard Operating Procedure.
b. In your March 3, 2006 response to Observation 5 of the Form FDA 483, you responded that a Temporary Deviation Authorization procedure was established to ensure that deviations from manufacturing specifications are properly authorized before implementation. Please provide a copy of your Temporary Deviation Authorization procedure with your response to this letter.
c. In your March 3, 2006 responses to Observations 3 and 5 of the Form FDA 483, you indicated that the deviations occurred due to the failure of personnel to follow standard operating procedures (SOP). Your corrective action for both observations involves retraining of personnel to ensure procedures are followed. Please explain how will you determine the effectiveness of your corrective action, since the root cause of this deviation was failure to follow Sops.
2. We note that in your responses to Observation 6 of the Form FDA 483, you responded that repair personnel neglected to document the replacement of the front panel label every time a unit was repaired. In your corrective action, you stated that all employees were retrained and the Device History Records of all Blood/Fluid warmers were reviewed for repairs done in 2006 and were found to be in compliance. However, you did not address whether Device History Records for 2005 repairs would be reviewed and amended, as necessary, to reflect any corrective actions taken on those devices.
3. In your March 3, 2006 letter, you stated that many of the observations made during the January 18, 2006 to February 15, 2006 inspection relate to problems which pre-dated the previous 2004 inspection, after which you undertook a comprehensive corrective action program. We note that the corrective action plan described in your March 2006 submissions appears to prospectively focus on the correction and improvement of your operations. Your corrective actions should also address products in distribution and should not be limited to new production.
Please notify this office in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to correct the noted violations, including (1) the time frames within which the corrections will be completed, (2) any documentation indicating the corrections have been achieved, and (3) 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.
Your response should be sent to Laurence D. Daurio, Compliance Officer, at the above address.
Steven B. Simpson
Acting District Director