| Public Health Service Food and Drug Administration |
| Baltimore District Office 6000 Metro Drive, Suite 101 Baltimore,MD 21215-3215 Telephone: (410) 779-5454 |
Department of Health and Human ServicesFEI: 3004585612
WARNING LETTER
CMS# 98966
March 11, 2010
CERTIFIED MAIL
RETURNED RECEIPT REQUESTED
Paul D. Cumming, Ph.D., President
Talisman Ltd.
421 Church Street, NE
Suite F
Vienna, Virginia 22180
Dear Dr. Cumming:
During an inspection of your firm located at the above-referenced address from November 02, 2009 through November 12, 2009, an investigator from the United States Food and Drug Administration (FDA or Agency) determined that your firm manufactures Automated Blood Grouping and Antibody Test Systems. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 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 is intended to affect the structure or any function of the body.
This inspection revealed that your 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, its manufacture, packing, storage, or installation are not in conformity with the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) Regulation found at Title 21, Code of Federal Regulations (C.F.R), Part 820.
We received and reviewed your response dated December 4, 2009 and March 5, 2010 and have determined that it is inadequate in that it does not address all the observations cited in the FDA-483 you received at the end of the inspection.
FDA follow-up inspections will be necessary to assure that your firm's corrections are adequate.
The violations include, but are not limited to, the following:
1. Failure to have a justification for not reporting corrective or removal action to FDA by a designated person. [21 C.F.R. § 806.20(b)(4)] Specifically, your firm distributed patches (b)(4) and (b)(4) for release to correct failures of the Quality Donor System, revision 2.11 and no documented justification was reported to FDA. Your response adequately addressed this observation.
2. Failure to establish procedures for conducting quality audit. [21 C.F.R. 820.70(i)] Specifically, there is no documented evidence that the software, (b)(4) and (b)(4) you used during the manufacturing process of the Quality Donor System, version 2.11, was validated.
3. Failure to have completed and implemented procedures to control the design process. [21 C.F.R 820.30(a)] Specifically, SOP, (b)(4) (approved 5/11/06), is incomplete in that it does not fully address the design control requirements for:
a. Design Plan: This procedure does not assure that a design plan describing or referencing the design and development activities, and responsibility for implementation are documented.
b. Design Input: This procedure does not include a mechanism for addressing incomplete, ambiguous, or conflicting requirements.
4. Failure to establish procedures for conducting quality audits. [21 C.F.R. 820.22] Specifically, your firm's quality audit policy, "Quality Audit" (rev. 1.01, approved 9/29/05) states that internal quality audits will be conducted yearly. However, your firm has not established a quality audit procedure describing how quality audits are to be conduced to assure that your quality system is in compliance with the quality system requirements and to determine the effectiveness of your quality system.
5. Failure to have complete complaint handling procedures for receiving complaints. [21 C.F.R. 820.198(a)] Specifically, your firm uses (b)(4) to receive, review and evaluate complaints. However, your SOP (b)(4) (dated 3/29/05), does not described this practice. Also, you have not established an appropriate procedure to describe the instructions so all complaints are processed in a uniform and timely manner.
6. Failure to establish procedures for identifying training needs. [21 C.F.R. 820.25(b)] Specifically, your firm does not have procedures that address the requirement to identify and document training needs. In addition, your firm does not maintain documented qualifications for your (b)(4) who is responsible for developing and refining software; Quality Specialist, who is response for assuring validity an safety of released product; and Director Operations, who is responsible for complaint handling systems, documents, validation methods, SOP approval, etc. Your response adequately addressed this observation.
7. Failure to establish procedure for addressing documentation of corrective and preventive action activities. [21 C.F.R. 820.100] Specifically, your firm's corrective and preventive action (CAPA)policy, "Corrective and Preventive Action" (rev. 1.01, approved 9/29/05) states that the firm will implement appropriate CAPA based on the root cause identified during the investigation and evaluation of the quality data that is inputted to the CAPA system. However, your firm has not established CAPA procedures addressing requirements for data sources to be analyzed with appropriate statistical methods for the identification of existing product, and quality problems that require corrective action, and for the timely receipt, investigation, verification, validation, and documentation of corrective and preventive actions prior to their implantation. Your response adequately addressed this observation.
You should take prompt action to correct the violations addressed in this letter. We acknowledge that you promised corrective actions to be made by December 31, 2009. 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 that they may take this information into account when considering the award of contracts. Requests for Certificates to Foreign Governments will not be granted until the violations related to the subject devices have been corrected.
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 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. 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 occurring again. 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 action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.
Please direct your response to: Randy F. Pack, Compliance Branch Director, U.S. Food and Drug Administration, 6000 Metro Drive, Suite 101 Baltimore, MD 21217. If you have any questions, please contact Mr. Pack at (410) 779-5417.
Sincerely yours,
/S/
Evelyn Bonnin
Baltimore District Director
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