| Public Health Service Food and Drug Administration |
Chicago District |
Department of Health and Human ServicesNovember 8, 2010
WARNING LETTER
CHI-01-11
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Mr. Robert H. Thrun
President
Anchor Products Company, Inc.
52 West Official Road
Addison, IL 60101-4519
Dear Mr. Thrun:
During an inspection of your firm located in Addison, Illinois conducted on May 26 through June 4, 2010, investigator(s) from the United States Food and Drug Administration (FDA) determined that your firm manufactures the Anchor Tissue Retrieval System and other laparascopic, ophthalmic, biopsy, and veterinary 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 are intended to affect the structure or 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 (CGMP) requirements of the Quality System (QS) regulation found at Title 21, Code of Federal Regulations (CFR), Part 820. We received a response from you dated July 22, 2010, concerning our investigator's observations noted on the Form FDA 483, Inspectional Observations, that was issued to you. We did not address this response below because it arrived more than 15 working days after the close of the inspection. We will address this response with your response to this letter. The violations include, but are not limited to, the following:
1. Failure to establish and maintain adequate procedures for receiving, reviewing, and evaluating complaints by a formally designated unit and for promptly reviewing, evaluating, and investigating any complaint that represents an event that must be reported to FDA under part 803 of this chapter, as required by 21 CFR 820.198 (a) and (d). For example, your firm's written complaint procedure (Complaints and Corrective & Preventive Action, Doc #PR 13.0), dated 1/10/2010, does not address what types of"events" will require reporting to FDA under part 803, Medical Device Reporting.
2. Failure to establish and maintain adequate procedures to ensure review, evaluation and investigation of any complaints involving the possible failure of a device, labeling, or packaging to meet any of its specifications unless such investigation has already been performed for a similar complaint, as required by 21 CFR 820.198(c). For example, Complaint #010, Anchor Tissue Retrieval System (model TRS 100SB2, lot number QI9N), was received on January 21, 2010, with complaint description, (b)(6) , placed the introducer through the trocar and advanced the handle completely forward ... While pushing the specimen deeper into the bag, the plastic molding snapped on the introducer system and came loose in the abdomen." Your firm did not respond to the customer's inquiry, "Please let me know what to do with the contaminated components I retrieved after the procedure." and annotated the Anchor Products Complaint Findings block as "Cannot examine - No Sample". Additionally, the customer's Product Incident Report states the product was returned to Anchor Products; however, the Product Director/Product Manager stated he could not recall receiving defective product and stated, "Why would they send us contaminated product."
3. Failure to establish and maintain adequate procedures to ensure the maintenance of adequate records of the investigation made under Section 820.198 by the formally designated unit, as required by 21 CFR 820.198(e). For example, complaint investigations involve visual inspections of returned product. These visual inspections were not documented according to a statement made by a company official and photographs are not kept. The visual results of the investigation were not included as part of the record of the investigation.
4. Failure to establish and maintain adequate corrective and preventive action procedures for analyzing processes, work operations, concessions, quality audit reports, quality records, service records, complaints, returned product, and other sources of quality data to identify existing and potential causes of nonconforming product, or other quality problems as required by 21 CFR 820.100(a)(1). For example, Doc # PR 13.0, dated January 10,2010, Complaints and Corrective & Preventive Action Procedure only addresses actions in response to product complaints and does not address other sources quality problems or data.
5. Failure to establish and maintain adequate procedures for the identification, documentation, validation or where appropriate verification, review, and approval of design changes before their implementation, as required by 21 CFR 820.30(i). For example, an Engineering Change Order (ECO) was not created to document the design changes made to the Anchor Tissue Retrieval System as required by your firm's design change procedure, Product Design and Development, Doc #PR 6.0, Section 3.10 Design Changes. These design changes, e.g., a change from the material (b)(4) to (b)(4) were incorporated in models TRSIOOSB2 and TRS175SB2 and sold to customers. The first shipment of the Anchor Retrieval System model TRS I00SB2 and the Anchor Retrieval System model TRS175SB2 was on October 20, 2009 and February 1, 2010, respectively. Your firm only had an unsigned and undated document noting the changes conducted.
6. Failure to establish and maintain adequate procedures to control all documents that are required by Part 820 that shall provide for the designation of an individual(s) to review for adequacy and approve prior to issuance all documents established to meet the requirements of this part and the documentation of the approval including the date and signature of the individual(s) approving the document, as required by 21 CFR 820.40(a). For example:
a. Your firm's Document Control Procedure, dated 12/7/2009, section 3.5 states, "Forms: These documents are produced by a streamlined creation and control process. Any department manager or area supervisor may develop a new form for use in their area." The procedure states in section 8.1 Creating New Forms that "forms do not require an approval signature" and states in section 8.2 Review and Approval that "Forms may be reviewed and approved by the Department Manager or Area Supervisor of the primarily [sic] area affected by the form."
b. The plant manager documented 14 CAPAs (CARs) on an unapproved form titled, "Corrective/Preventive Action Plan (FM01-003)," that is not referenced and/or described in the firm's Complaints and Corrective & Preventive Action Procedure (Doc # PR 13.0, dated January 10, 2010).
c. Your firm's complaints were documented on an unapproved form titled, "Complaint Registration Form" which has no approval signature and/or revision date.
7. Failure to establish and maintain an adequate organizational structure to ensure that devices are designed and produced in accordance with the requirements of Part 820, as required by 21 CFR 820.20(b). For example, during the inspection, two different employees stated that he was the management representative. Also, another employee stated that the management representative was not documented.
Our inspection also revealed that your Anchor Tissue Retrieval System devices, Models TRS100SB and TRS175SB, are misbranded under section 502(t)(2) of 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 C.F.R. Part 803 - Medical Device Reporting (MDR) regulation. Significant deviations include, but are not limited to, the following:
1. Failure to submit a report to FDA no later than 30 calendar days after the day that you received or otherwise became aware of information, from any source, that reasonably suggests that a device that you market may have caused or contributed to a death or serious injury, as required by 21 CFR Part 803.50(a)(1).
For example:
Complaint Number 07 (Exhibit #25) describes an event that occurred in October 2009 that met the definition of serious injury. The complaint includes evidence that the malfunction of the device (i.e., device metal arm breakage) necessitated medical intervention (i.e., surgery) to retrieve metal parts of the broken device which were left inside the patient's abdomen from a prior procedure (i.e., removal of cyst) to preclude permanent impairment of a body function or permanent damage to a body structure.
2. Failure to submit a report to FDA no later than 30 calendar days after the day that you received or otherwise became aware of information, from any source, that reasonably suggests that a device that you market has malfunctioned, and this device or a similar device you market would be likely to cause or contribute to a death or serious injury if the malfunction were to recur, as required by 21 CFR Part 803.50(a)(2).
For example:
Complaint Numbers 05,010,012,013, and 014 represent events where the device broke during a procedure and pieces of the device had to be retrieved from the patient. Please note that because Complaint Number 07 established that a malfunction of the device (i.e., breakage during a procedure), could necessitate medical intervention to retrieve broken parts of the device, any malfunction of the device (i.e., breakage of the device during a medical procedure) that occurred after mid October 2009, is likely to cause or contribute to a serious injury. Therefore, Complaint Numbers O5, 010, 012, 013, and 014 are reportable malfunctions that should have been submitted as MDRs to FDA.
3. Failure to provide for internal systems that assure timely and effective identification, communication and evaluation of events that may be subject to MDR requirements, as required by 21 CFR 803.17.
For example:
Your firm's written complaint procedure, Complaints and Corrective & Preventive Action, does not address what types of "events" will be reported to the FDA, the time frames required for reporting these "events" nor how these "events" will be reported to the FDA.
You should take prompt action to correct the violation(s) addressed in this letter. Failure to promptly correct these violation(s) 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 deviations 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 (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 violation(s), or similar violation(s), from occurring again. Include documentation of the corrective action you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.
Your response should be sent to: Matthew J. Sienko, Compliance Officer. If you have any questions about the content of this letter please contact: Mr. Sienko at (312) 596-4213 or Fax (312) 596-4195.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violation(s) at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violation(s) 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 problems in your firm's manufacturing and quality assurance systems. You should investigate and determine the causes of the violation(s), and take prompt actions to correct the violation(s) and to bring your products into compliance.
Sincerely,
/s/
Scott J. MacIntire
District Director
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