Inspections, Compliance, Enforcement, and Criminal Investigations
Lee Medical International, Inc. 23-Jun-05
Department of Health and Human Services
Public Health Service
New Orleans District
June 23, 2005
WARNING LETTER NO. 2005-NOL-26
Mr. Gerald P. Tauzier, President
Lee Medical International, Inc.
612 Distributors Row
Harahan, Louisiana 70123
Dear Mr. Tauzier:
On February 3, 7, 11, 17, March 3, 11, and 14, 2005, the U.S. Food and Drug Administration (FDA) conducted an inspection of your firm, located at 612 Distributors Row, Harahan, Louisiana. FDA has determined your firm manufactures various dialysis and catheter kits. These products are devices as defined by Section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act). You may find the Act and associated regulations through links at FDA's home page at www.fda.gov.
The above-stated inspection revealed the devices are adulterated under Section 501(h) of the Act, as the methods used in, or the facilities or controls used for, their manufacture, 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, as specified in Title 21, Code of Federal Regulations (CFR), Part 820. Significant deviations found during the inspection include, but are not limited to, the following:
1. Failure to conduct and/or document adequate corrective and preventive action in response to complaints involving the possible failure of your device to meet its specifications, as required by 21 CFR 820.100(a) and (b). For example, there is no record of any corrective and preventive action taken in response to four complaints (see Form FDA 483 observation #3).
2. Failure to conduct follow-up investigations to complaints involving the possible failure of your devices to meet specifications and failure to document the reason why no investigation was conducted, as required by 21 CFR 820.198(b) and (c). For example, our investigator reviewed and documented four complaints involving the components in your dialysis and catheter kits dated between September 2003 and April 2004. These records establish your firm did not conduct an investigation in response to these complaints, nor did anyone record any reason explaining why no investigation was conducted (see Form FDA 483 observation #3c).
3 . Failure to document if each batch of finished devices met acceptance criteria before releasing them for distribution, as required by 21 CFR 820.80(d) . For example, your firm failed to sample the following kits to determine if they met device specifications: ISO-102, manufactured January 19, 2004; 70450-BAYLOR, manufactured January 28, 2005; and, GOODSAM-HEMO, manufactured February 3, 2005 (see Form FDA 483 observation #12).
4. Failure to establish and maintain procedures to ensure all purchased or otherwise received product conform to specified requirements, as required by 21 CFR 820.50. Specifically, your firm failed to establish and maintain the requirements, including quality requirements, which must be met by suppliers, contractors, and consultants. For example, your firm failed to maintain data clearly describing or referencing the specified requirements for purchased or otherwise received product and services, in particular, sterilization of your products (see Form FDA 483 observation #13).
5. Failure to prepare and approve device master records (DMR) for each type of kit you manufacture, as required by 21 CFR 820.181. The DMR for each type of device must include the device specifications; production process specifications; quality assurance procedures and specifications; packaging and labeling specifications; and, installation, maintenance, and servicing procedures and methods, if necessary (see Form FDA 483 observation #7).
6. Failure to maintain device history records (DHR) for each kit you manufacture to ensure each product is manufactured in accordance with the DMR, as required by 21 CFR 820.184. For example, your firm does not record product labels, component lot numbers, finished device lot or control numbers, along with documentation of label review (see Form FDA 483 observation #6).
7. Failure to ensure an adequate and effective Quality System has been implemented and maintained at all levels of your organization, as required by 21 CFR 20.20. For example, under this regulation, your firm is responsible for conducting sufficient and regular internal quality system audits, evaluations of suppliers/contractors, and sufficient management review meetings (see Form FDA 483 observation #4).
8. Failure to conduct internal audits of your quality system, as required by 21 CFR 820.22 (see Form FDA 483 observation #9).
9. Failure to conduct management reviews at defined intervals and with sufficient frequency, as required by 21 CFR 820.20(c) (see Form FDA 483 observation #4).
10. Failure to establish and maintain procedures to control all documents, as required by 21 CFR 820.40. For example, your firm has not designated an individual to review and approve documents. Your firm has not established procedures to control changes to documents so they are reviewed and approved by an individual in the same function or organization performing the original review and approval, unless specifically designated otherwise (see Form FDA 483 observation #14).
11 . Failure to establish and maintain procedures to control labeling activities used for manufacturing your dialysis and catheter kits, as required by 21 CFR 20.120 (see Form FDA 483 observation #6c).
12. Failure to establish and maintain procedures for control and distribution of finished devices to ensure only those devices approved from release are distributed and purchase orders are reviewed before the devices are released, as required by 21 CFR 820.160(a). For example, your firm failed to establish and maintain procedures to ensure expired or deteriorated devices are not distributed (see Form FDA 483 observation #5c).
Additionally, the above-stated inspection revealed your devices are misbranded under Section 502(t)(2) of the Act . Specifically, your firm failed or refused to furnish any material or information required by or under Section 519 respecting the device and 21 CFR 803 Medical Device Reporting (MDR) regulation.
Significant violations include, but are not limited to, the following:
1. Failure to establish adequate written Medical Device Reporting (MDR) procedures, as required by 21 CFR 803.17, to provide for timely and effective identification, communication, and evaluation of events subject to medical device reporting requirements, and a standardized review process/procedure for determining when an event meets the criteria for reporting (see Form FDA 483 observation #2).
2. Failure to submit a report within 30 days after receiving or becoming aware of information which reasonably suggests a device has malfunctioned and such device would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur, as required by 21 CFR 803.50(a)(2). For example, your firm failed to submit four IVDR reports to FDA within 30 days for complaints concerning the following (see Form FDA 483 observation #1a-d).
a. On or about October 28, 2004, your firm received a complaint regarding a disposable syringe in which the needle detached from the green hub and leaked out medication.
b. On or about August 11, 2004, your firm received a complaint indicating the luer lock broke off inside a patient's catheter while removing the syringe from the catheter port during a dialysis procedure. The syringe was removed from the catheter using hemostats.
c. On or about March 3, 2004, your firm received a complaint indicating the drip chamber of one of the Lee Medical Bloodlines separated causing blood to escape the corporal system.
d. On or about April 15, 2003, your firm received a complaint indicating the syringes in the firm's dialysis kits malfunctioned while being used on 10 - 12 patients. Specifically, liquid came out of the top of the syringes past the plunger while flushing out the blood line.
3. Failure to conduct an investigation of each of the above events and an evaluation of the cause of each event, as required by 21 CFR 803.50(b)(2) (see Form FDA 483 observation #3).
4. Failure to establish and maintain an MDR event file, as required by 21 CFR 803.18(a) and (b) (see Form FDA 483 observation #3).
This letter is not intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to ensure adherence to each requirement of the Act and regulations. The specific violations noted in this letter and in the Form FDA 483 issued at the close of the inspection may be symptomatic of serious underlying problems in your firm's manufacturing and quality assurance systems. You are responsible for investigating and determining the causes of the violations identified by the FDA. You also must promptly initiate permanent corrective and preventive action on your quality system.
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, no premarket submissions for Class III devices to which the Quality System regulation deficiencies are reasonably related will be cleared or 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 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 Food and Drug Administration without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties.
We have received your response to the Form FDA 483, dated April 11, 2005, regarding our investigator's observations noted on the Form FDA 483 issued at the closeout of the Harahan facility inspection. Although we acknowledge your firm's efforts to come into compliance with FDA's regulations, you failed to provide any supporting documentation which indicates you have implemented the actions mentioned in your response. Although the corrections summarized in your response appear to be adequate, supporting documentation or procedures will need to be submitted for our review.
Please notify this office in writing within fifteen (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 prevent the recurrence of similar violations. If corrective action cannot be completed within 15 working days, state the reasons for the delay and the time within which the corrections will be completed.
Your response should be directed to Mark W. Rivero, Compliance Officer, U.S. Food and Drug Administration, 6600 Plaza Drive, Suite 400, New Orleans, LA 70127.
If you need assistance in understanding the contents of this letter, please contact Mark Rivero, Compliance Officer, at the above address or at (504) 253-4519.
H. Tyler Thornburg
New Orleans District