Inspections, Compliance, Enforcement, and Criminal Investigations
Winspan, Inc. 27-Jun-06
Department of Health and Human Services
Public Health Service
Los Angeles District
RETURN RECEIPT REQUESTED
June 27, 2006
6403 Jessie Street
San Fernando, California 91340
Dear Mr. Irwin:
During an inspection of your firm located in San Fernando, California on January 26, 2006 through February 1, 2006, our investigator(s) determined that your firm manufactures the CPReviver Models Mini, 100, and 2100, non-rebreathing valves.
The CPReviver Models Mini, 100, and 2100, non-rebreathing valves are medical devices because they are intended for use in the cure, treatment, prevention, or diagnosis of a disease or medical condition; or because they are intended to affect the structure or any function of the body. [Federal Food, Drug, and Cosmetic Act(the Act), Section 201(h), [21 U.S.C. 321(h)]
The CPReviver Models 100 and 2100 were FDA cleared (K864125 and K871147) as emergency manual ventilators, a class 11 device. 21 CFR 868.5915. In 1995 FDA sent a letter informing your firm that the devices should have been classified as non-rebreathing valves, a class II device. 21 CFR 868. 5870. The classification regulation for a non-rebreathing valve states that it is a one-way valve that directs breathing gas flow to, the patient and vents exhaled gases into the atmosphere." Since submitting your Premarket Notifications you have modified your labeling for the CPReviver Model 100 and Model 2100 to state that they "protect[s] against backflow of fluids or contagious diseases" and "block[s] passage of contagious diseases." The labeling also claims the devices " ...can be easily cleaned and sanitized for reuse." Because you did not receive premarket clearance or approval from FDA to offer your devices for protection against contagious disease or for reuse, marketing it for these new intended uses is a violation of the law. Specifically, the devices are adulterated under section 501(f)(1)(B) of the Act, [21 U.S.C. 351(f)(1)(B)], in that they are class III devices under section 513(f) ofthe Act, 21 U.S.C. 360c(f), and do not have approved applications for premarket approval in effect pursuant to section 515(a) of the Act, [21 U.S.C. 360e(a)] or approved applications for an investigational device exemption under section 520(g) of the Act, [21 U.S.C. 360j(g)]. The devices are, also misbranded under section 502(o) of the Act, (21 U.S.C. 352(o)], in that a notice or other as information respecting the new intended uses of the devices was not provided to the FDA required by section 510(k), (21 U.S.C. 360(k)), and 21 CFR 807.81(a)(3)(ii). For a device requiring premarket approval, the notification required by section 510(k) of the Act, [21 U.S.C. 360(k)], is deemed satisfied when a PMA is pending before the agency. 21 CFR 807.81(b).
This inspection also 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 (CGMP) requirements of the Quality System (QS) regulation found at Title 21, Code of Federal Regulations (CFR), Part 820. Significant violations include, but are not limited to, the following:
1. Management with executive responsibility has not ensured that a quality policy has been fully implemented and maintained at all levels of the organization. Specifically,
a. There is no quality policy and objectives, as required by 21 CFR 820.20(a).
b. Procedures for conducting quality audits have not been established to determine effectiveness of the quality system, as required by 21 CFR 820.22.
c. Procedures for management to review the Quality System procedures for suitability and effectiveness have not been established, as required by 21 CFR 820.20(c).
2. Complaint handling procedures for receiving, reviewing, and evaluation of complaints
have not been established. Specifically,
a. A complaint handling procedure has not been established nor is there any procedure to evaluate complaints, as required by 21 CFR820.198(a).
b. There is no preset file to document complaints, as required by 21 CFR 820.198(a).
c. There is no Medical Device Reporting (MDR) procedure nor any policy developed to evaluate events to determine if they meet the criteria for reporting an MDR reportable event, as required by 21 CFR 803.17.
3. Acceptance activities were not fully documented as required by 21 CFR 820.80(e). Specifically, the firm does not document that the 100% functional air test [redacted] Tester) is properly performed by the appropriate personnel on the finished product.
4. There were no procedures to ensure that the [redacted] Tester used to test the completed CPReviver (finished product) was routinely calibrated nor was there documentation of any calibrations performed. Specifically,
a. There is no written procedure or schedule for calibration of the [redacted] Tester, as required by 21 CFR 820.72(a).
b. There is no documentation ofthe calibration dates, the individual, performing each calibration, and the next calibration date for the [redacted] Tester, as required by 21 CFR 820.72(b)(2).
5. Procedures for identifying product throughout all stages of receipt, production, distribution, and installation are not established, as required by 21 CFR 820.60. Specifically, the firm does not have a procedure for identifying components (manufactured in-house) used in the assembly of the CPReviver.
6. Products that do not conform to specifications are not adequately controlled, as required by 21 CFR820.90(a). Specifically, defective components (manufactured in-house) that are used in the assembly of the CPReviver were observed to be co-mingled with adequate components (manufactured in-house) in the assembly room.
The CPReviver Model 2100 device is also misbranded under section 502(f)(1), [21 U.S.C. 352(f)(1)J in that the labeling for the device fails to bear adequate directions for use for the purposes for which it is intended because adequate directions for lay use cannot be written for a non-rebreathing valve that extends into the airway more than 2 cm since only a trained professional would be capable of using such a device. Your device is not exempt from the requirements of 502(f)(1), [21 U.S.C. 352(f)(1)] of the Act under 21 CFR 801.109, because the labeling does not bear the statement:
"Caution: Federal law restricts this device to sale by or on the order of a ______ ", the blank to be filled with the word physician, dentist, veterinarian, or with the descriptive designation of any other practitioner licensed by the law of the State in which he practices to use or order the use of the device.
This letter is not intended to be an all-inclusive list of deficiencies 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 Inspectional Observations, Form FDA 483 (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 should investigate and determine the causes of the violations, and take prompt actions to correct the violations and to bring your products into compliance.
You should take prompt action to correct these deviations. Failure to promptly correct these deviations may result in regulatory action. These actions include, but are not limited to, seizure, injunction, and/or civil penalties. Additionally, no applications for premarket approval for Class III devices to which QS regulation deficiencies are reasonably related will be approved until the violations have been corrected. Also, no requests for Certificates for Products for Export will be granted until the violations related to the subject devices have been corrected. Also, Federal agencies are informed about the Warning Letters we issue, such as this one, so that they may consider this information when awarding government contacts.
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 all documentation of the corrective action you have taken. If you plan to make any corrections in the future, include those plans with your response to this letter as well.
Please submit your response to:
Pamela B. Schweikert
Director, Compliance Branch
Food and Drug Administration
Irvine, CA 92612-2445
If you have any questions relating to this letter please contact Compliance Officer John Stamp at 949-608-4464.
Alonza E. Cruse
Los Angeles District Office
cc: Department of Health Services
Food and Drug Branch
P.O. Box 997413, MS-7602
Sacramento, CA 95899-7413