Inspections, Compliance, Enforcement, and Criminal Investigations
Bass Medical Inc 02/12/2009
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|New Orleans District|
404 BNA Drive
Building 200 -Suite 500
Nashville, TN 37217
Telephone: (615) 366-7801
FAX: (615) 366-7802
February 12, 2009
WARNING LETTER NO. 2009-NOL-03
Delivery Signature Requested
Julie A. Ryan, Owner
Bass Medical, Inc.
2539 John Hawkins Parkway, Suite 101
Birmingham, Alabama 35244
Dear Ms. Ryan:
During an inspection of your firm, located at 1211 Highland Gate Lane, Hoover, Alabama on September 24 and 26, 2008, an investigator from the United States Food and Drug Administration (FDA)determined your firm is a specifications developer of a Class II Device, Bass Fluid Control System. Under Section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 United States Code (USC) 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 these devices are adulterated within the meaning of Section 501(h) of the Act [21 USC 351(h)], because the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation do not conform with the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation found at Title 21, Code of Federal Regulations, Part 820 (21 CFR 820). A Form FDA483, Inspectional Observations (483) was issued to you, which listed the following violations:
1. Failure to establish quality system procedures and instructions [21 CFR 820.20(e)]. There are no quality system procedures and instructions for your device.
2. Failure to establish and maintain procedures for implementing written corrective and preventive action (CAPA) procedures for your device [21 CFR 820.100(a)]. There are no CAPA procedures for your device.
3. Failure to establish and maintain procedures for acceptance activities for your device [21 CFR 820.80(a)]. There are no written procedures for inspections, tests, or other verification activities for incoming components, in-process product, or for the finished device.
4. Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints [21 CFR820.198(a)]. Although your firm contracts with an outside contractor to receive and answer incoming complaints, you failed to establish written procedures to ensure the regulatory requirements were met.
5. Failure to establish and implement written procedures to ensure all purchased products and services conform to specified requirements [21 CFR 820.50]. There are no purchasing controls to ensure components and contract manufacturing services meet established specifications. Further, your purchasing documents did not include an agreement in which your suppliers and contractors agree to notify you of any changes in the product or service so which you can determine whether such changes may affect the quality of the finished device.
6. Failure to establish and maintain procedures to ensure the device history record for each batch, lot, or unit is maintained to demonstrate the Bass Fluid Control System is manufactured in accordance with the device master record [21 CFR 820.184]. There are no procedures to ensure which device history records for your device are manufactured in accordance with the device master record and other applicable requirements in the QS regulation in 21 CFR 820.
Our inspection revealed your Bass Fluid Control System devices are misbranded under Section 502(t)(2) of the Act, 21 USC 352(t)(2). Your firm failed or refused to furnish material or information regarding the device, as required by Section 519 of the Act, 21 USC 3601, and 21 CFR 803 - Medical Device Reporting (MDR) regulation. Significant deviations include, but are not limited to, the following:
1. Failure to implement written MDR procedures for internal systems which provide for timely and effective identification, communication, and evaluation of events which maybe subject to MDR requirements, as required by 21 CFR 803.17(a)(1). For example:
a. When the investigator requested all MDR procedure documents, (b)(4) was the only document provided;
b. Document (b)(4) does not describe the actions to be taken when you receive customer complaints;
c. A description of how complaint investigations are to be conducted and documented was not included in this procedure;
d. Instructions for the timely completion and transmission of MDRs to FDA were not included in this procedure; and,
e. This procedure, (b)(4) referenced another procedure (b)(4) which apparently describes how your firm addresses MDR. However, this procedure was not provided at the time of the inspection.
2. Failure to implement written MDR procedures for internal systems which provide for a standardized review process or procedure for determining when an event meets the criteria for reporting under this part, as required by 21 CFR 803.17(a)(2). For example, a procedure for determining when an event meets the criteria for reporting was not provided at the time of the inspection.
3. Failure to develop, maintain, and implement written MDR procedures for documentation and record keeping requirements for systems which ensure access to information that facilitates timely follow-up and inspection by FDA, as required by 21 CFR 803.17 (b)(4). For example, you failed to provide the referenced document (b)(4) to the investigator at the time of the inspection.
You should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations 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 money penalties. Also, federal agencies are advised of the issuance of all warning letters about devices so they may take this information into account when considering the award of contracts. Additionally, premarket approval applications for Class III devices to which the QS 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 violations, or similar violations, from recurring. 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 actions cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.
Your response should be sent to: Kari L. Batey, Compliance Officer, U.S. Food and Drug Administration at the address above. If you have any questions about the content of this letter please contact Ms. Batey at (615) 366-7808.
This letter is not intended to be an all-inclusive list of the 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 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.
H. Tyler Thornburg
New Orleans District
Enclosure: Form FDA 483