Inspections, Compliance, Enforcement, and Criminal Investigations
Silent Call Communications Corp. 25-Mar-05
Department of Health and Human Services
Public Health Service
RETURN RECEIPT REQUESTED
March 25, 2005
Mr. George J. Elwell
Silent Call Communications Corp.
5095 Williams Lake Road
Waterford, MI 48329
Dear Mr. Elwell:
An inspection of your facility was conducted on January 18th through 31st, 2005. The purpose of the inspection was to evaluate the adequacy of your activities related to the manufacturing of finished medical devices. The Personal Alert Systems as well as other medical products manufactured by your firm are medical devices as defined by Section 201(h) [21 USC 321(h)] of the Federal Food, Drug and Cosmetic Act (the Act). This inspection revealed that the devices are adulterated under the Act, as explained further below.
Our inspection revealed that your firm is operating in violation of the Quality System (QS) Regulation, Title 21, CFR Part 820, in that the methods used in, or the facilities used for the manufacture/assembly, packing and storage of these finished medical devices intended for human use, are not in compliance with the current Good Manufacturing Practice (cGMP) requirements. Significant deviations include, but are not limited to, the following:
1 . Your firm failed to establish an effective management control system as required by 21 CFR 820.20. [See, for example, FDA-483 observation 1].
a. No quality policy has been implemented or documented.
b. No quality plan has been defined or established.
c. Management reviews have not been documented.
d. Quality system procedures have not been defined.
2. Your firm failed to establish quality system procedures as required by 21 CFR 820(e) to address each of the operations listed below. [See, for example, FDA-483 observations 5, 7, 8, & 9].
a. No procedures for acceptance of components, manufacturing materials, in-process devices and finished devices as required by 21 CFR 820.80 for identifying whether or not products conform to acceptance criteria as required by 21 CFR 820.86.
b. No procedures for implementing corrective and preventive actions as required by 21CFR 820.100.
c. No procedures to control the production processes as required by 21 CFR 820.70. For example, there are no documented instructions, standard operating procedures and methods that define and control the manner of production to ensure the devices conform to specifications.
d. No procedures for the evaluation of suppliers, contractors and consultants as required by 21 CFR 820.50(a).
3. Your firm failed to document acceptance test results of incoming, in-process and finished devices as required by 21 CFR 820.80(b)-(d). [See, for example, FDA-483 observation 6].
4. Your firm failed to maintained device history records as required by 21 CFR 820.184. Finished devices were released for distribution [See, for example, FDA-483 observations 3-5].
a. No documented review to assure the devices was made in accordance with the device master record.
b. No indication that the devices met defined specifications.
c. No record of the actual label or labeling.
d. No record of the manufacturing dates, quantity or date released.
5. Your firm failed to conduct any quality audits as required by 21 CFR 820.22. [See, for example, FDA-483 observation 2].
6. Your firm failed to provide training to ensure employees adequately perform their assigned responsibilities as required by 21 CFR 820.25(b). For example, you have not provided training for employees to assure proper application of the Quality System Regulation has been met. [See, for example, FDA-483 observation 11].
7. Your firm has failed to establish procedures for medical device reporting as required by 21 CFR 820.198. See also 21 CFR 803.17. Failure to file a medical device report required by 21 USC 360i and 21 CFR Part 803 causes your medical devices to be misbranded within the meaning of section 21 USC 352(t)(2). See also 21 USC 331(q)(1)(B).
This letter is not intended to be an all-inclusive list of your firm's compliance status . It is your responsibility to assure adherence to each requirement of the federal regulations. Other Federal agencies are advised of the issuance of all Warning Letters about medical devices so that they may take this information into account when considering the award of contracts.
We request that you take prompt action to correct these violations. Failure to promptly correct violations may result in enforcement action being initiated by the Food and Drug Administration without further notice. The Federal Food, Drug, and Cosmetic Act provides for the seizure of illegal products, the assessment of civil money penalties, and for injunction against the manufacturer and/or distributor of illegal products.
Please notify this office in writing within fifteen (15) working days of your receipt of this letter, of any additional steps you plan to take or intend to take to bring your firm into compliance. If corrective actions cannot be completed within 15 working days, please state the reason for the delay and the time frame which the corrections will be implemented. Your written reply should be directed to Paige E. Wilson, Compliance Officer at the above address.
David M. Kaszubski
Acting District Director
Detroit District Office