Inspections, Compliance, Enforcement, and Criminal Investigations
Phoenix Instruments, Inc. 11/8/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
November 8, 2012
Via UPS Next Day
Phoenix Instruments, Inc.
2368 Corporate Lane, Suite 106
Naperville, Illinois 60563
Dear Mr. Javed:
During an inspection of your firm located in Naperville, Illinois, from July 10, 2012, through August 1, 2012, an investigator from the United States Food and Drug Administration (FDA) determined that your firm relabels and repackages Class I and Class II surgical instruments, which include, for example, Mogen circumcision clamps, Debakey vascular clamps, Pratt uterine dilators, and Hoen nerve hooks. 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 function of the body.
The inspection revealed that these devices are adulterated within the meaning of Section 501(h) of the Federal Food, Drug, and Cosmetic Act (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.
Your firm’s response, dated August 21, 2012, to the Form FDA 483 (FDA 483) was reviewed and determined to not adequately address all of the violations cited on the FDA 483. These violations include, but are not limited to, the following:
1. Failure to adequately ensure, when the results of a process cannot be fully verified by subsequent inspection and test, that the process shall be validated with a high degree of assurance and approved according to established procedures, as required by 21 CFR 820.75(a).
For example: Your firm has not validated the (b)(4) etching process according to established procedures to ensure that it does not adversely affect the products. Mr. Adnan Javed, your firm’s Vice President, was unable to provide the investigator with validation results for the (b)(4) etching process.
2. Failure to adequately maintain procedures for acceptance of incoming product. Incoming product shall be inspected, tested, or otherwise verified as conforming to specified requirements. Acceptance or rejection shall be documented, as required by 21 CFR 820.80(b).
a) Your firm has a specification for purchased product verification to document incoming inspection activities for the Mogen Circumcision Clamp. Your firm uses the Specification for Purchased Product Verification (b)(4) form to document incoming inspection activities for the Mogen Circumcision Clamp. Five out of five forms reviewed did not have the following documented:
• Inspection Type
• Equipment Used
• Non-Conforming Product (if rejected)
• Inspected by (sign/date)
b) According to your firm’s "Receiving Inspection Procedure" (unsigned/undated), "the Inspector inspects the lots of material
according to . . . specifications using the Receiving Inspection Checklist Form." This form was not maintained as per your firm’s
procedure. In addition, 5 out of 5 of your firm’s Specification for Purchased Product Verification sheets, used solely for inspection of the Mogen Circumcision Clamp, were not completed as required.
3. Failure to establish an adequate quality plan that defines the quality practices, resources, and activities relevant to devices that are designed and manufactured, as required by 21 CFR 820.20(d).
a) Your firm's Standard Operating Protocol, the Quality Plan, was originally signed on March 10, 2012. Thereafter, on July 11, 2012 (a date during the inspection), the Quality Assurance Manager and Annual Reviewer signed and dated the Standard Operating Protocol. However, as the firm’s President, you had not signed or formally approved the Standard Operating Protocol as required.
b) Your firm did not have a documented Quality Plan prior to March 09, 2012. (b)(6), your firm’s Quality Control Manager, indicated that all previous procedures (procedures prior to March 09, 2012) were maintained on a shared drive and that those were overwritten on the shared drive and no longer exist, except for the Standard Operating Protocol.
Our inspection also revealed that your Mogen circumcision clamps are misbranded under Section 502(t)(2) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 352(t)(2), in that your firm failed or refused to furnish material or information respecting the device that is required by or under Section 519 of the Act, 21 U.S.C. § 360i, and 21 CFR Part 803 – Medical Device Reporting (MDR) regulation. Significant deviations include, but are not limited to, the following:
Failure to submit an MDR to the Food and Drug Administration within 30 calendar days after the day that you receive or otherwise become aware of information, from any source, that reasonably suggests that the device that you marketed may have caused or contributed to a death or serious injury, as required by 21 CFR 803.50(a)(1).
For example: On March 16, 2012, your firm was made aware of a reportable serious injury event involving a Mogen circumcision clamp being used during a procedure. Your firm did not submit an MDR to the FDA for this event.
You 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 Food and Drug Administration 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. 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 you have taken to correct the noted violations, as well as an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions you have taken. If your planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of these activities. If corrections and/or corrective actions cannot be completed within 15 business days, state the reason for the delay and the time within which these activities will be completed. Your response should be comprehensive and address all violations included in this Warning Letter.
Your response should be sent to: Carrie Ann Plucinski, Compliance Officer, Food and Drug Administration, 550 W. Jackson Blvd., 15th floor, Chicago, Illinois 60661. Refer to the Unique Identification Number (CMS case # 346158) when replying. If you have any questions about the content of this letter, please contact Ms. Plucinski at 312-596-4224.
Finally, you should know that 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 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.
Scott J. MacIntire