- Carousel Solutions LLC dba Xtract Solutions
- Issuing Office:
- Seattle District Office
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
22215 26th Ave SE, Suite 210
Bothell, WA 98021
August 11, 2014
In reply refer to Warning Letter SEA 14-17
James M. Baker, President and CEO
Carousel Solutions, LLC, dba Xtract Solutions
9495 SW Locust Street, Suite E
Portland, Oregon 97223
Dear Mr. Baker:
During an inspection of your firm located in Portland, Oregon, on April 21 - 24, 2014, an investigator from the United States Food and Drug Administration (FDA) determined that your firm is a specification developer of the Syringe Key and ER-SHOT devices. 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 to affect the structure or any function of the body.
This inspection revealed that these 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, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820.
We received your response, dated May 13, 2014, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, that was issued to your firm. We address the response below, in relation to each of the noted violations. These violations include, but are not limited to, the following:
1. Failure to establish and maintain procedures to ensure that the design requirements relating to a device are appropriate, as required by 21 CFR 820.30(c). For example, you indicated that your firm does not have written dosing precision and accuracy requirements for your ER-SHOT device.
The adequacy of your firm’s response cannot be determined at this time. We acknowledge the operating parameters to include dosing tolerance per ISO standards. You have not provided the ISO standards from which you are applying dosing tolerances.
2. Failure to establish and maintain procedures for verifying the device design, as required by 21 CFR 820.30(f). For example, your firm failed to conduct design verification to ensure that product design outputs met defined design input requirements as identified in your document Design Specification, ER-SHOT DS-80.
a. Design verifications listed in this document include requirements that the device will function as designed for at least (b)(4) and that you will retain (b)(4)mm and (b)(4)mm vial closures. When requested, you could provide no evidence to indicate compliance with these requirements.
b. Design verifications listed in the document include an operating temperature range of (b)(4)°C. The upper limit of this operating temperature is identified in component literature as the initial mold temperature. When presented with this information, you indicated this upper temperature limit may not adequately represent actual operating conditions.
c. Design verifications listed in the document include cleaning after every use, and the labeling for this product identifies the use of alcohol as a cleaning agent. During the inspection, you identified isopropyl alcohol as the appropriate cleaning agent. You have not tested the components of this device to determine the adequacy of this compound as a cleaning agent for your device, and if your device can withstand repeated exposure to this compound.
In addition, you failed to establish acceptance criteria, including mean and standard deviation dosing values, for device design verification.
We reviewed your firm’s response and conclude that it is not adequate. Your response did not provide any evidence that your device has a shelf life of (b)(4) or that you are presently retaining (b)(4)mm and (b)(4)mm vial closures, as indicated in either your previous or revised ER-SHOT Design Input documents. You have not provided documentation of verification and validation testing for operating temperature, to include the rationale for the change in the upper temperature parameter. Further, you have not provided specific ER-SHOT device cleaning protocols outlined in section 18.104.22.168 of your Design Specification: ER-SHOT DS-80. As such, we are unable to evaluate if you have determined the adequacy of the cleaning agent expected to be employed by the user to clean this device. We accept your revised ER-SHOT design input identifying a dosing value is 0.50mL per the identified ISO standard. However, you have not supplied a mean or standard deviation dosing value. As explained above, you have not provided the ISO standard from which you are applying dosing tolerances for dosing. As such, your response as it pertains to established acceptance criteria for device design verification cannot be evaluated.
3. Failure to establish and maintain procedures to validate the device design, as required by 21 CFR 820.30(g). For example, your firm identifies the following (b)(4) tests for validation of the ER-SHOT device: (b)(4). You have failed to identify predetermined acceptance criteria for any of these tests.
We have reviewed your firm’s response and conclude that it is not adequate. Your verification and validation steps identified in your Verification Plan VP-080 include only acceptance criteria for the weight and measurements of the ER-SHOT case. This document makes reference to sub-assembly specifications, but does not identify those specifications specifically, nor does it include acceptance criteria for the Syringe Keys. Your response indicates that you are no longer using the tests identified in the violation above.
4. Failure to establish procedures to ensure that the device design is correctly translated into production specifications, as required by 21 CFR 820.30(h). For example, your firm does not maintain documentation to support the review and approval of production records related to your ER-SHOT design project, as outlined in your procedures.
The adequacy of your firm’s response cannot be determined at this time, as you have not provided your revised design control procedure, SOP No.: 100-01, nor have you provided specific corrective actions you plan to implement, based on this revised procedure, to prevent this violation from recurring in the future.
5. Failure to establish and maintain procedures to control all documents, as required by 21 CFR 820.40. For example, your firm made available for use the following product labels and labeling prior to review and approval, as required by your firm’s labeling and packaging procedure, Labeling and Packaging SOP No. 300-06:
- ER-SHOT Label – document number 120-0024 R1
- ER-SHOT User Guide – document number SM025
- ER-SHOT Instructional Flash Drive 120-0020
- Document titled Using the Syringe Keys (For Use with Prescription Only)
We have reviewed your firm’s response and conclude that it is not adequate. Your response does not include any reference as to whether you intend to continue distributing devices with labels and labeling still under review.
6. 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 example, your firm has not implemented the following requirements of your firm’s supplier qualification procedure, Supplier Qualification SOP No. 600-02:
a. You failed to routinely evaluate the criticality of the material, assembly, product, or service provided by each supplier, as required by your procedure, Supplier Qualification SOP No. 600-02.
b. You failed to routinely document the extent of control or frequency of re-evaluations of your suppliers, or establish a supplier qualification schedule for audit or submission of a qualification questionnaire, as required by your procedure, Supplier Qualification SOP No. 600-02.
The adequacy of your firm’s response cannot be determined at this time. Your response indicates that, at the time your response was submitted to FDA for review, you had taken no action to correct this violation. Further, you have provided no documentation to support corrections you plan to implement to correct this violation and prevent it from recurring in the future.
7. Failure to establish procedures to ensure that sampling methods are adequate for their intended use, and written and based on valid statistical rationale, as required by 21 CFR 820.250(b). For example, (b)(4) test records for the Syringe Key Final Inspection for your firm’s (b)(4) 1mL compatible Syringe Key devices did not have an established sampling plan, to include statistical rationale, prior to sampling for finished device inspection. Sampling for finished device inspection for this lot of Syringe Keys was conducted on April 28-29, 2010. Your firm’s procedure governing such sampling, and the statistical rationale for sampling, was approved on August 31, 2010.
We have reviewed your firm’s response and conclude that it is not adequate. Your response indicates that, at the time your response was submitted to the FDA for review, you had taken no action to correct this violation. Further, you have provided no documentation to support corrections you plan to implement to correct this violation and prevent it from recurring in the future.
8. Failure to conduct quality audits to assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system, as required by 21 CFR 820.22. For example, your firm’s quality audit procedure Internal Quality Audit SOP No 500-02 Rev NEW, dated August 31, 2010, required internal quality audit schedules to be established annually. Your last documented internal audit was conducted on October 26, 2010.
We have reviewed your firm’s response and conclude that it is not adequate. Your response, dated May 13, 2014, indicates that your projected date for conducting a quality audit is within 90 days. Your most recent documented quality audit was conducted on October 26, 2010. Your proposed timeframe of ninety days does not include statements to support this timeframe.
Your firm 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 civil money penalties. Also, federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information into account when considering the award of contracts. Additionally, premarket approval applications for Class III devices to which the Quality System regulation violations 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 business days from the date you receive this letter of the specific steps your firm has taken to correct the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (which must address systemic problems) that your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm’s response should be comprehensive and address all violations included in this Warning Letter.
Your firm’s response should be sent to: Seattle District Office, 22215 26th Avenue SE, Suite 210, Bothell, Washington 98021-4425. Refer to the Warning Letter SEA 14-17 when replying. If you have any questions about the contents of this letter, please contact: LCDR Cynthia White, Compliance Officer at (425) 302-0422.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems. Your firm should investigate and determine the causes of the violations, and take prompt actions to correct the violations and bring the products into compliance.
Miriam R. Burbach