Inspections, Compliance, Enforcement, and Criminal Investigations
Titan Scan Technologies 19-Jul-01
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
Denver District Office
Bldg. 20 Denver Federal Center
P.O. BOX 25087
6th Avenue & Kipling Street
Denver, Colorado 80225-0087
July 19, 2001WARNING LETTER
RETURN RECEIPT REQUESTED
Louis T. Ruggiero, President and CEO
Titan Scan Technologies
9020 Activity Road, Suite D
San Diego, California 92196
Ref # DEN-01-42
Dear Mr. Ruggiero:
The Food & Drug Administration (FDA) conducted an inspection of your firm located at 6750 East 46th Avenue Drive, Suite 100, Denver, Colorado 80216, on February 27, 28, March 1, and March 5, 2001. At that time, Consumer Safety Officer Lori A. Lahmann determined you operate a medical device contract sterilization facility using electron beam technology. Processing of these products, which are considered devices within the meaning of Section 201 (h) of the Federal Food, Drug and Cosmetic Act (the Act), cause your facility to be under the jurisdiction of the FDA. A copy of the FD-483, List of Observations, is attached for your ready reference. We regret the delay in issuing this letter to you.
The above inspection revealed that the devices processed by your firm are adulterated within the meaning of Section 501 (h) of the Act, in that the methods used in, or the facilities or controls used for the manufacture, packing, storage, or installation of these devices are not in conformity with the Quality System Regulation (QSR), as specified in Title 21, Code of Federal Regulations, Part 820 (21 CFR 820), as follows:
- Failure to establish and maintain an adequate quality system that is appropriate forthe specific medical devices designed and manufactured by your firm, as required by21 CFR 820.5.
- Failure to provide adequate resources, including the assignment of trained personnel for assessment activities, to meet the requirements of the QSR, as required by 21 CFR 820.20(b)(2). For example, resources have not been provided to assure that the quality requirements of the QSR are met.
- failure for management to review and evaluate a process and perform revalidation where appropriate when changes or process deviations occur, as required by 21CFR 820.75(c). For example, no revalidation was conducted to determine the effects of [redacted] unapproved engineering changes performed by a facility operator, which resulted in [redacted].
- Failure to establish and maintain procedures for implementing corrective and preventative action (CAPA) to include:
not analyzing all significant sources of quality data, and using appropriate statistical methodology where necessary to detect, recurring quality problems, as required by 21 CFR 820.100(a)(l). For example, normal parameters versus "spikes in operational faults are not analyzed to determine possible problem areas. We found that, between January 2000 and February 2001, the monthly numbers of [redacted] varied from incidents per month. These fault codes were not analyzed to determine if there was a potential problem area;
not identifying the action needed to correct and prevent recurrence of nonconforming
product and other quality problems, as required by 21 CFR 820.100(a)(3). For example, there are no procedures to consistently document when the [redacted] Accelerator or conveyor fails, and when the system recoveries occur. These failures and recoveries are to be documented on the Operator?s Shift Reports, however, Our inspection noted that not all [redacted] which were found on the computer were reported on the Operators Shift Reports, and therefore were not reviewed by management;
and not verifying or validating the CAPA to ensure that such an action is effective and does not adversely affect the finished device, as required by 21 CFR 820.100(a)(4), For example, chain speed has been changed in your facility without any validation nor verification that the change is appropriate and adequate.
- Failure to establish and maintain procedures for changes to a specification, method,
process or procedure, as required by 21 CFR 820.70(b), For example, chain speeds are changed without justification.
- Failure to establish and maintain procedures for rework, to include retesting and reevaluation of the nonconforming product after rework, to ensure the product meets its current approved specifications, as required by 21 CFR 820.90(b)(2). For example, a [redacted] lot was underdosed. The product was augmented to bring the minimum dose close to above the targeted range, however, there are no procedures for performing this rework.
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 FDA-483 issued at the closeout 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. If the causes are determined to be systems problems, you must promptly initiate permanent corrective actions.
You should take prompt action to correct these and any other manufacturing or quality systems deviations identified by your internal audits. Failure to promptly correct these deviations may be identified in a follow-up inspection, and 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 penalties.
Please notify this notice in writing, within 15 days of receipt of this letter, of the additional steps you will be taking to achieve compliance which have not been previously reported to us. Your reply should be sent to the Food and Drug Administration, Denver District Office, Attention: Shelly L, Maifarth, Compliance Officer, at the above address. You may contact her at (303) 236-3046 if you have any questions about this letter.
Thomas A. Allison
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