Inspections, Compliance, Enforcement, and Criminal Investigations
CooperSurgical, Inc. D.B.A. Lone Star Medical Products 4/25/13
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
4040 North Central Expressway
Dallas, Texas 75204-3128
April 25, 2013
UPS OVERNIGHT MAIL
Mr. Paul Remmell
President and Chief Executive Officer
95 Corporate Dr.
Trumbull, CT 06611
Dear Mr. Remmell:
During an inspection of your firm, Lone Star Medical Products, Inc. located in Stafford, Texas on July 10, 2012 through August 6, 2012, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures Uterine Manipulator Handle, Koh-Efficient and Stays 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 reviewed a response dated August 27, 2012, from Thomas G. Williams, Vice President of Business Assurance and Regulatory Affairs on behalf of Lone Star Medical Products, concerning our investigator's observations noted on the Form FDA-483 (FDA-483), lnspectional Observations, which was issued to your firm. We conclude that this response is not adequate or, in some cases, the adequacy of the response cannot be determined because, although your firm promises to make various corrections, the response did not include supporting evidence of these corrections. We address this response below, in relation to each of the noted violations. These violations include, but are not limited to, the following:
1. Failure to maintain complaint files and failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a). For example, your firm's MDR Determination Form, QAR002, was not utilized for Complaint #'s 2502, 2504, 2505 and 2506 on the KC-RUMI Koh-Efficient devices, all dated 5/22/12, and describing vaginal lacerations that required suturing. Your firm did not document any efforts to obtain additional information about these events or retrieve the products from the hospital/complainant. Your firm also did not document that there was a previous, similar event (Complaint #1980/MDR #1216677-2012-0006) from a different customer on 2/7/12. Additionally, Complaint #2555, opened 5/31/12, regarding another case of vaginal lacerations that required suturing, reported by the same customer and on the same product lot number (Lot 122272) as Complaint #2504, was filed as an MDR report (#1216677-2012-0012) on 6/25/12; however, complaint file #2555 does not contain an MDR Determination Form, QAR002, nor did it document any follow up on the returned device or investigation by your firm.
We reviewed your firm's response and conclude that it is not adequate. Your firm's response states that a CAPA was opened as a follow-up to this observation. It further stated that based on investigations conducted by your firm, it was determined that all the complaints cited in this observation pertained to one device being used by one physician, in one incident. However, your firm did not provide supporting documentation to verify these assertions. Further, no information was provided to demonstrate that a retrospective review of complaints was conducted to ensure that the complaint investigations were completed as required. In addition, no information was provided to address whether complaints listed in the current observation and all previously reported complaints were evaluated to determine if they are MDR reportable.
2. Failure to review, evaluate, and investigate any complaint 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 and another investigation is not necessary, as required by 21 CFR 820.198(c). For example, Product Complaint Report #2545 opened 5/30/12, regarding a Lone Star Stays 3333-4G mislabeling issue, did not document any complaint investigation or corrective action information in the Complaint Analysis portion of your firm's Product Complaint Report Form QAR-001, as required by your firm's Complaint Procedure QAR-003. Also, there was no documentation for why an investigation was not conducted.
We reviewed your firm's response and conclude that it is not adequate. Your firm's response states that a CAPA was initiated. However, no evidence was provided to demonstrate that a correction and/or a corrective action for this deficiency were implemented. In addition, no documentation was provided to demonstrate that an investigation was conducted and documented for this complaint, and that all other complaints were retrospectively reviewed to ensure they were completed as required.
3. Failure to promptly review, evaluate, and investigate by a designated individual(s) any complaint that represents an event which must be reported to FDA under 21 CFR Part 803 and failure to maintain these complaints in a separate portion of the complaint files or otherwise clearly identified, as required by 21 CFR 820.198(d). For example, your firm completed an MDR Determination Form QAR002, for Product Complaint Report #1226 involving a RUMI II Handle UMH650 which broke during use because your firm received a copy of the MedWatch report from the user facility. The MedWatch Report showed that the complaint was reported by the user facility to FDA as a serious product problem on 8/2/11. Your firm's complaint file, however, did not document a rationale on the MDR Determination Form, QAR002, for why the event is not MDR reportable, nor was this form reviewed or signed by your firm's Regulatory Affairs management, in accordance with your firm's Complaint Procedure.
We reviewed your firm's response and conclude that it is not adequate. Your firm's response states that a follow-up review of this complaint was conducted. It further states that corrections were made to the MDR Determination Form, to include the rationale for why an MDR was not required. However, your firm did not provide supporting documentation to demonstrate that a corrective action was implemented to ensure that this deficiency does not recur. In addition, no documentation was provided to demonstrate that a retrospective review of all MDR forms has been completed.
4. Failure to maintain a record of the investigation by a formally designated unit identified in 21 CFR 820.198(a), when an investigation is made under 21 CFR 820.198, as required by 21 CFR 820.198(e). For example, Product Complaint Report #1937 (opened 1/31/12 and closed 5/21/12) involved an Arch KohEfficient, KC-Arch-30, which became loose from the handle inside the patient during a Total Laparoscopic Hysterectomy with a (b)(4). The physician discontinued the (b)(4) and it became necessary to surgically remove the uterus; however, this was not adequately investigated and documented. Specifically, the complaint file did not include: explanation of how the problem occurred or why open surgery was required; lot information on the devices used during the procedure; a rationale by the responsible company official as to why the incident was deemed not MDR reportable; record of product query search done for the complaint; and any written response to the customer. The Complaint Analysis portion of the form was not completed until 5/21/12 (more than 30 days after the date the complaint was received).
We reviewed your firm's response and conclude that it is not adequate. Your firm's response states that a CAPA was initiated and that documentation on file has been updated to include an amended MDR Determination Form that includes the rationale for why an MDR was not required. However, no supporting documentation was provided as evidence of the reported corrections and no information was provided to document that a retrospective review of all preexisting complaints has been completed.
5. Failure to establish and maintain procedures for implementing corrective and preventive action, including requirements for investigating the cause of nonconformities relating to product, processes, and the quality system and identifying the action(s) needed to correct and prevent recurrence of nonconforming product and other quality problems, as required by 21 CFR 820.100(a)(2) and (3). For example, your firm received approximately 220 complaints of UMH650 RUMI II handles and wires breaking and your firm documented root causes on CAPAs opened to address these complaints; however, your firm failed to implement adequate investigation measures to differentiate between product failure based on improper product usage and product failure due to product defects.
We reviewed your firm's response and conclude that it is not adequate. Your firm's response states that investigations are incomplete and that several CAPAs are ongoing in an effort to establish whether product failure was based on defective product or improper usage. It was further stated that your firm is in the process of revamping its CAPA procedures to address the currently inadequate complaint handling procedures. However, no evidence was provided to support ongoing corrections and corrective actions to ensure the CAPAs in the observation are investigated as required, and that effective corrective actions have been identified.
6. Failure to establish and maintain 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).
A. ECN #9688 initiated to (b)(4) RUMI II Handle component (Part 37270), as a result of 7 complaints, did not describe the validation and/or verification to be completed or required for the (b)(4) change. There was no documentation that the change did not alter the risk analysis by reference to the supporting product risk management document. Additionally, the related complaints were not attached as noted.
B. ECN #10058, initiated to add a (b)(4) to all Ultem components to address (b)(4) issues and to add (b)(4) to part number 37291, did not include the supporting "Validation/Risk Analysis" documents for the two changes on the Rumi Koh-Efficient components prior to approval, and in accordance with the Cooper Surgical ECN Procedure, BSR-ENG-002. Additionally, this ECN was not signed and filed as 'Completed'.
C. ECN #10063 documents that Validation/Risk Analysis was required for this design change involving the RUMI Tip and Body Arch II. The Validation & Risk Analysis Memo attached to this ECN states that the changes to the (b)(4) and (b)(4) arch body do not need to be validated since the same processes/features were previously validated in other Uterine Manipulator Handles. The ECN further states the design was verified using two sample arches built with the modified (b)(4) to ensure that adding a (b)(4) would prevent the RUMI tip rods from (b)(4) during use; however, this supporting verification test was not referenced in or attached to the ECN. Additionally, the ECN did not document any applicable complaint numbers in the Reason for Change section, although Complaint 1612/MDR #1616677-2011-0022 appears to be applicable.
We reviewed your firm's response and conclude that it is not adequate. Your firm's response stated that a new ECN procedure has been implemented and that further modifications are ongoing. However, no evidence was provided to support implementation of your proposed corrective action for this deficiency. Further, no evidence was provided to demonstrate that the ECNs listed in the above observation were validated and/or verified, reviewed, and approved. In addition, your firm did not provide evidence that a retrospective review of all preexisting design changes previously implemented were validated and/or verified, reviewed and approved and that employees were trained on all revised procedures pertaining to this deficiency.
7. Failure to validate a process with a high degree of assurance and approve the process according to established procedures where the results of a process cannot be fully verified by subsequent inspection and test, as required by 21 CFR 820.75(a). For example, the verification qualification (VQ) protocol for the UMH650 RUMI Assembly Procedure dated 1/10/11, states that your firm is responsible for "process validation of assembly procedure." The protocol required a sampling size of (b)(4) units for VQ testing; however only (b)(4) units were used with no justification for the reduced sampling size. In addition, the protocol did not define the statistical technique used to establish the sample size for data collection and analysis.
We reviewed your firm's response and conclude that it is not adequate. Your firm's response states that an ongoing CAPA identified deficiencies with your firm's current process for validation activities and processes. It is further stated that you intend to implement a more robust product validation protocol, including well supported statistical techniques for data collection and analysis. However, your firm did not provide evidence to demonstrate that validation of the UMH650 RUMI Assembly Procedure was completed as required. In addition, no evidence was provided to demonstrate that a retrospective review of all processes was completed to ensure they were validated as required.
Our inspection also revealed that your devices are misbranded under section 502(t)(2) of the Act, 21 USC § 352(t)(2), in that your firm failed or refused to furnish material or information respecting the devices that is required by or under section 519 of the Act, 21 USC § 360i, and 21 CFR Part 803 - Medical Device Reporting (MDR) Regulation. Significant deviations include, but are not limited to:
Failure to submit a report to FDA no later than 30 calendar days after the day that you receive or otherwise become 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 803.50(a)(1). For example, the events referenced in Complaints #2502, 2504, 2505, and 2506 include information that reasonably suggests that your firm's devices may have caused or contributed to an injury (i.e. vaginal lacerations) that required sutures. Suturing vaginal lacerations represents medical intervention that was necessary to preclude permanent impairment of a body function or permanent damage to a body structure. An MDR should have been submitted for each complaint
In addition, Complaint #1980 (MDR#121667-2012-00006) and Complaint #2555 (MDR#121667-2012-0012) were incomplete because they failed to identify the ''Type of reportable event" in Section H.1 of the FDA Form 3500A as "serious injury." Your firm should submit a supplemental report for each referenced MDR to correct the event type.
If your firm wishes to submit MDR reports via electronic submission it can follow the directions stated at the following URL: http://www.fda.gov/Forlndustry/FDAeSubmitter/ucm107903.htm
If your firm wishes to discuss MDR reportability criteria or to schedule further communications, it may contact the MDR Policy Branch at 301 -796-6670 or by email at ReportabilityReviewTeam@fda.hhs.gov.
Our inspection also revealed that your firm's Lone Star Retractor System Elastic Stays, Spira 2-Finger, product #3333-4G devices 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 CFR Part 806 - Medical Devices; Reports of Corrections and Removals. Specifically, your firm failed to maintain a record of a correction or removal that is required to be reported to FDA, in accordance with 21 CFR 806.20(a).
Specifically, your firm failed to maintain a record of the correction and removal conducted to remedy confirmed customer complaint #2545 for incorrect Stay components in Lone Star Retractor System Elastic Stays, Spira 2-Finger, product #3333-4G, lot #122507. This lot was distributed to two customers and you received a formal customer complaint on May 30, 2012. You retrieved this product from the complainant on June 6, 2012, and reworked the retrieved product and the product in your finished goods inventory to replace the incorrect Stay components. You failed to maintain a record of the correction and removal action to include the device name and model identification, a description of the events that led to the correction and removal action, a justification for not reporting the correction or removal action to FDA that included conclusions, follow-ups, and reviews by a designated person, and copies of all communications regarding the correction or removal action. Your complaint record also failed to document the results of your investigation, to include root cause and corrective and preventive action, and your correction and removal action failed to adequately address all impacted distributed product.
You notified the second customer on July 10, 2012, that they "(b)(4)" however, you did not provide the customer with sufficient information to identify any nonconforming product nor did you inform the customer of the specific product nonconformance (incorrect Stays), or provide the customer with instructions regarding what to do with the nonconforming product.
The adequacy of your firm's response cannot be determined at this time. Your firm's response states that Complaint Procedure, BSR-QAR-003, is currently being reviewed and revised to clarify the documentation and record maintenance practices for determining and implementing corrective and removal actions and that efforts are underway to implement a new SOP. However, no supporting documentation was provided to facilitate an effective review of the proposed corrections.
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 Ill 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 (including any systemic corrective actions) 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 the Food and Drug Administration, 4040 North Central Expressway, Suite 300, Dallas, Texas 75204, Attention: Rose Ashley, Compliance Officer. Refer to the Unique Identification Number 2013-DAL-WL-033 when replying. If you have any questions about the contents of this letter, please contact: Rose Ashley at (210) 308-1407.
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 lnspectional 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.
Reynaldo R. Rodriguez, Jr.
Dallas District Director
Thomas G. Williams, VP Business Assurance and Regulatory Affairs
95 Corporate Drive
Trumbull, CT 06611
Marc Gelnett, Director of Operations
Lone Star Medical Products
11211 Cash Rd.
Stafford, TX 77477