Inspections, Compliance, Enforcement, and Criminal Investigations
Catch Incorporated 06-Apr-05
Department of Health and Human Services
Public Health Service
Telephone : 425-486-8788
April 6, 2005
VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 05-19
Glenn H. Kawasaki, President
11822 North Creek Parkway North, Suite 107
Bothell, Washington 98011
Dear Mr. Kawasaki:
On February 9-11, 16, 18, and 24, 2005, a Food and Drug Administration (FDA) investigator conducted an inspection of your establishment located at 11822 North Creek Parkway North, Suite 107, Bothell, Washington. FDA has determined that your establishment is a specification developer of the Homogeneous Enzymic Homocysteine Reagent test system which is defined as a medical device under section 201(h) [21 U.S.C. 321(h)] of the Federal Food, Drug, and Cosmetic Act (the Act).
Our inspection revealed that this device is 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 manufacturing, packing, storage, or installation are not in conformance with the current Good Manufacturing Practice (cGMP) requirements for medical devices which are set forth in the Quality System Regulation (QSR), 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 by a formally designated unit, as required by 21 CFR 820.198(a). For example, your firm had no approved written procedure for the handling of a complaint involving the potential for iron assay interference with the homocysteine assay.
2. Failure to maintain a Device Master Record which includes device specifications, production process specifications, quality assurance procedures, packaging and labeling specifications, and installation, maintenance, and servicing procedures, as required by 21 CFR 820.18.
3. Failure to establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements, as required by 21 CFR 820.50. For instance, you have not established and maintained the requirements, including quality requirements that must be met by [REDACTED] for purchased enzymes used in the manufacture of the Homogeneous Enzymic Homocysteine Reagent test system.
4. Failure to establish and maintain procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a). For example, your firm had no approved written corrective and preventive action procedure in place to verify or validate the corrective and preventative action initiated for iron assay interference with the homocysteine assay and to ensure that the subsequent change in package insert language was effective.
5. Failure to establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met, as required by 21 CFR 820.30. For example, design controls were not established and maintained to include design and development, design inputs and outputs, design review, design verification, design validation, design transfer, and design changes.
This letter is not intended to be an all-inclusive list of 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 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 violations and take prompt actions to correct the violations and to bring your products into compliance. 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 QSR deficiencies are reasonably related will be cleared until the violations have been corrected. Also, no requests for Certificates for Products for Export will be approved until the violations related to the subject devices have been corrected.
You should take prompt action to correct these deviations. Failure to promptly correct these deviations may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil penalties. Please notify this office within 15 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 system problems necessary to ensure that similar violations will not recur. Please include any and all documentation to show that adequate correction has been achieved . In the case of future corrections, an estimated date of completion, and documentation showing plans for correction should be included with your response to this letter.
Please send your reply to the Food and Drug Administration, Attention: Lisa M. Althar, Compliance Officer, 22201 23rd Drive SE, Bothell, Washington 98021-4421. If you have questions regarding any issue in this letter, please contact Lisa M. Althar at (425) 483-4940.
Charles M. Breen