Source: https://www.fda.gov/iceci/enforcementactions/warningletters/2014/ucm457836
Timestamp: 2019-02-16 15:10:30
Document Index: 441204251

Matched Legal Cases: ['§ 321', '§ 360', '§ 360', '§ 352', '§ 360', '§ 360', '§ 381']

Vinyas Innovative Technologies Pvt., Ltd. 12/12/14
Mr. N. Narendra
KIADB Plot No. 19, Sy. No. 26 & 273-P
Mysore 570 018
During an inspection of your firm located in Mysore, India,on August 14, 2014, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures ViScope. 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.
We received a response from T.R. Srinivasan, Director, dated September 8, 2014, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, which was issued to your firm. 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 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's process validation procedure states that a process validation plan “includes the acceptance criteria for validation to be acceptable. . . . The inspection process must also be validated to ensure that it consistently accepts conforming product and reject nonconforming product." However, your firm did not validate the (b)(4) processes. Your firm used first article inspection, but did not establish operating parameters using a valid statistical rationale.
We reviewed your firm’s response and conclude that it is not adequate. Establishing a new requirement to document the quantity of products will not ensure that the process is validated. Your firm did not review its process validation procedure to ensure that qualifications are performed according to established procedures and acceptance criteria, which are documented in an approved protocol. Your firm did not provide evidence that the (b)(4) processes have been properly validated. In addition, your firm did not perform a retrospective review of other manufacturing processes to ensure that process validations were adequately performed.
2. Failure to establish and maintain procedures for monitoring and control of process parameters for validated processes to ensure that the specified requirements continue to be met, as required by 21 CFR 820.75(b). For example, your firm has not established procedures for monitoring and controlling process parameters of validated processes.
We reviewed your firm’s response and conclude that it is not adequate. Your firm provided a document titled “(b)(4),” which was created to document tolerances. However, the document does not show how your firm’s processes produce conforming products throughout the range of process inputs. Specifically, your firm’s document:
Does not include data from operational qualifications that establish a range of operating parameters (e.g., temperature, time, cooling time, speed, pressure, etc.);
Does not establish tolerance ranges for the current operating parameters; and
Does not show how your firm monitors and controls the process parameters.
3. Failure to establish and maintain procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a). For example, your firm’s procedure for corrective action indicates the following:
a. Your firm’s procedure includes requirements that quality data from a variety of sources will be analyzed. However, your firm’s procedure does not employ the use of appropriate statistical methodology necessary to detect recurring quality problems.
b. Your firm’s procedure for corrective action states that “root causes are identified using corrective and preventive action form and appropriate corrective actions are taken.” "Task Force Meeting" spreadsheets are used by your firm to review all nonconformances. However, these spreadsheet records do not document an investigation of the cause of nonconformities relating to product, processes, or the quality system.
c. Your firm’s procedure for corrective action states that “The corrective action records are maintained by the concerned. . . . (sic) Where corrective actions are not achieved, draw the specific action plan to achieve the timely results.” However, the "Task Force Meeting" spreadsheet records for the nonconformances do not document the implementation of changes in methods and procedures needed to correct and prevent identified quality problems, specifically, by not identifying action plans to address ineffective corrective actions.
d. Your firm’s procedure for corrective action states that “the effectiveness of corrective actions taken is monitored periodically.” However, "Task Force Meeting" spreadsheet records, corresponding to three nonconformance investigations, do not document whether corrective actions were verified or validated as effective, or that the corrective actions do not adversely affect the finished device.
We reviewed your firm’s response and conclude that it is not adequate.
The response did not address the deficiency identified above in sub-paragraph a. Your firm did not review its CAPA process to determine if changes are necessary to address this deficiency and clearly communicate what steps it has taken to address this issue.
Regarding sub-paragraphs b, c, and d, your firm provided a sample of the report for one CAPA that included a chart of identified corrective and preventive actions for the (b)(4) manufacturing, which included possible root causes, and corrective and preventive actions that were identified for each root cause. However, your firm did not provide evidence of its implementation of corrective/preventive actions, specifically:
Revisions to CAPA procedures;
Verification or validation that corrective actions were effective and did not adversely affect the finished device;
Evidence that employee training has been conducted; and
A retrospective review of closed CAPAs to determine:
o if these CAPAs were properly documented once your firm establishes its revised CAPA procedure;
o if other root causes, and new corrective and preventive actions that result from that review, were identified; and
o if the corrections and/or corrective actions were verified or validated as effective.
4. Failure to establish and maintain procedures for rework, to include retesting and reevaluation of the nonconforming product after rework, to ensure that the product meets its current approved specifications and ensure that rework and revaluation activities are documented in the Device History Record (DHR), as required by 21 CFR 820.90(b)(2). For example, your firm has not documented rework and reevaluation activities in its DHRs. A Production Rework Report showed that rework was conducted by your firm; however, no documentation of rework was present in the DHR.
We reviewed your firm’s response and conclude that it is not adequate. Your firm stated that rework activities will be updated in the remarks of (b)(4) format in the future, with serial numbers of reworked devices. However, your firm did not submit evidence of implementation of revised rework and DHR procedures, including training of affected personnel. Also, your firm did not perform a retrospective review of DHRs to determine if these records were also missing rework documentation and provide evidence of corrective actions.
5. Failure to maintain complaint files and 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 Handling of Customer Complaints procedure does not establish that complaints are evaluated to determine if they are MDR reportable events under 21 CFR 803.
We reviewed your firm’s response and conclude that it is not adequate. This deficiency was not addressed in your firm’s response.
6. Failure to develop, maintain and implement written MDR procedures as required by 21 CFR 803.17. For example, your firm did not develop, maintain, and implement a written MDR procedure.
We reviewed your firm’s response and conclude that it is not adequate because, although your firm stated that it would provide a written response in the future addressing this issue, we have not received this additional information.
Under section 510 of the Act (21 U.S.C. § 360), manufacturers of medical devices are required to annually register with the FDA. In September 2007, section 510 of the Act was amended by the Food and Drug Administration Amendments Act of 2007 (Pub. L. 110-85) to require domestic and foreign device establishments to submit their annual establishment registration and device listing information to FDA by electronic means during the period beginning October 1st and ending December 31st of each year. 21 U.S.C. § 360(p). Our records indicate that your firm has not fulfilled annual registration and listing requirements for fiscal year 2014.
Therefore, all of your firm’s devices are misbranded within the meaning of section 502(o) of the Act, 21 U.S.C. § 352(o), in that the devices were manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act, 21 U.S.C. § 360, and were not included in a list required by section 510(j) of the Act, 21 U.S.C. § 360(j).
Given the serious nature of the violations of the Act, the ViScope electronic stethoscope device,manufactured by your firm is subject to refusal of admission under section 801(a) of the Act, 21 U.S.C. § 381(a), in that it appears to be adulterated. As a result, FDA is taking steps to refuse entry of these devices into the United States, known as “detention without physical examination,” until these violations are corrected. In order to remove the devices from detention, your firm should provide a written response to this Warning Letter as described below and correct the violations described in this letter. We will notify you regarding the adequacy of your firm’s responses and the need to re-inspect your firm’s facility to verify that the appropriate corrections and/or corrective actions have been made.
Your firm’s response should be sent to: Food and Drug Administration, Center for Devices and Radiological Health, Office of Compliance, Field Inspections Support Branch, White Oak Building 66, Rm 2622, 10903 New Hampshire Ave., Silver Spring, MD 20993. Refer to CMS case # 440123 when replying. If you have any questions about the contents of this letter, please contact: Daniel Walter,Chief, Foreign Enforcement Branch, by telephone +1 (301) 796-5587,or by fax +1 (301) 847-8139.