- Degania Medical Devices Pvt Ltd.
- Issuing Office:
- Center for Devices and Radiological Health
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||10903 New Hampshire Avenue|
White Oak Building 66
Silver Spring, MD 20993
DEC 23, 2014
VIA UNITED PARCEL SERVICE
Mr. Meir Weiss
Degania Medical Devices Pvt. Ltd.
251 Sector 6 IMT Manesar
Gurgaon, Haryana 122050
Dear Mr. Weiss:
During an inspection of your firm located in Gurgaon, Haryana, India, on August 25, 2014, through August 29, 2014, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures catheters. 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.
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 received a response from you dated September 12, 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 validate computer software for its intended use according to an established protocol, when computers or automated data processing systems are used as part of production or the quality system, as required by 21 CFR 820.70(i). For example, your firm uses (b)(4) as its operating system for in-process testing. This operating system has not been validated to ensure that test data are adequately controlled. Data files, which include tensile testing of the (b)(4) for the Foley catheters and sensor testing used to test the temperature sensor on the Temperature Sensor catheters, can be manipulated by testing operators.
We reviewed your firm’s response and conclude that it is not adequate. Corrections and corrective actions include requiring the back-up of test results to your firm’s server. Your firm also indicated that it is implementing a (b)(4) for the tensile testing machines. However, your firm has not validated the software used to support in-process activities. Your firm has not provided a retrospective review of all software used for device production to ensure it has been adequately validated for its intended use.
2. Failure to establish and maintain procedures to control product that does not conform to specified requirements, which shall address the identification, documentation, evaluation, segregation, and disposition of nonconforming product, as required by 21 CFR 820.90(a). For example:
a. Your firm’s nonconforming product standard operating procedure (SOP) states: “reject the non-conforming products according to the standing SOPs. Keep the rejected quantity separately from the ok products use the sticker form (b)(4) DMD to identify the rejected qty. (reference form (b)(4)).” However:
i. (b)(4) was in the bin with no identification on it;
ii. An additional bag of product, identified as “(b)(4)” was also in the bin; and
iii. Neither of the products were labeled with a (b)(4) DMD sticker.
The supervisor stated the non-conforming product should have been labeled according to the standing SOPs.
b. According to a supervisor in manufacturing (b)(4) products should be labeled using form (b)(4) DMD. However, six plastic tubs containing bags of different (b)(4) product were being stored by a supervisor’s desk without any identification.
We reviewed your firm’s response and conclude that it is not adequate. Your firm revised its SOP to add requirements that ensure proper product identification is used during in-process inspection. Your firm also revised SOP “(b)(4) Validation of Processes for Production,” and provided training to staff on this revised procedure. Your firm provided refresher training on (b)(4) and provided evidence of this training. Additionally, your firm has increased the frequency of its internal audit plan for all (b)(4). However, your firm has not performed a retrospective review of all manufacturing halls to determine if additional non-conforming product is present that is not properly identified according to its approved procedures.
3. Failure to establish and maintain procedures to control all documents, as required by 21 CFR 820.40. For example, your firm’s document control system (electronic records system) is not controlled according to your firm’s document management procedure. The procedure states, “(b)(4)” and “(b)(4).” However, standard operating procedures, work instructions, and forms can be downloaded, copied, and manipulated by employees. Specifically:
a. Three versions of Form (b)(4) DMD, Revision No. 02, were being used to record activities associated with the (b)(4) process; and
b. A computer used to generate product labels was accessed by multiple employees under one username and password.
The adequacy of your firm’s response cannot be determined at this time. Your firm checked and removed all uncontrolled documents from its facilities and set up user profiles for all controlled electronic files. Your firm compared all master documents/forms to all production (b)(4) to ensure that the use of uncontrolled/non-approved versions of documents had no impact on product. Your firm also reviewed all (b)(4) DMD generated forms (b)(4), verified the recorded data in the controlled form, and approved the documents via O/C quality. Your firm also updated its document management procedure to instruct employees to keep only current scanned documents with signatures and master copy stamped on each page in the corporate server. Training was given to all supervisors and associates on this updated procedure. However, your firm has not completed monitoring of the DMD systems.
Your firm indicated that a gap assessment for 21 CFR Part 11 will be completed for all DMD systems. These computers will be checked and monitored every six months for effectiveness of (b)(4) and the revised Internal Audit Plan. However, evidence of the completion of the 21 CFR Part 11 gap assessment has not been provided for review.
4. Failure to establish and maintain procedures to ensure that Device History Records (DHRs) for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the Device Master Record (DMR), as required by 21 CFR 820.184. For example, your firm’s procedure states, “All data (dates/data variables/observations etc.) recording in real time … shall meet criteria of acceptance.” However, several DHRs were changed or corrected after the initial recorded date, which included the addition of entries, changes to dates of operation, changes to the production process (b)(4), and changes to the acceptance of the data (b)(4). Specifically, the following records were changed or corrected:
a. Form (b)(4) DMD used to record set-up parameters for (b)(4); and
b. Form (b)(4) DMD used for (b)(4).
We reviewed your firm’s response and conclude that it is not adequate. Your firm performed and provided evidence of awareness training for its employees concerning Good Document Practice, which included additional training on your firm’s batch record handling procedure. Additionally, your firm will increase the frequency of its internal audits of (b)(4) to three times a year. However, your firm has not provided a retrospective review of all DHRs to ensure that all corrections to DHRs have been completed according to its approved procedures.
5. Failure to ensure that validation activities and results, including the date and signature of the individuals approving the validation and where appropriate the major equipment validated, are documented, as required by 21 CFR 820.75(a). For example, your firm failed to document process validation for the following (b)(4) used in device production:
Your firm’s response to this observation appears to be adequate.
6. Failure to document corrective and preventive actions and their results, as required by 21 CFR 820.100(b). For example, your firm’s corrective and preventive action (CAPA) procedure states “O/C should record the preventive action in Form No. (b)(4).” Documentation was missing for three CAPAs during the inspection. Your firm stated that these three CAPAs were documented using the (b)(4) database system. However, in searching this database, documentation for CAPA (b)(4) was not found.
We reviewed your firm’s response and conclude that it is not adequate. Your firm stated that the root cause was not updating the CAPA cancellation in the (b)(4) system. Your firm updated its procedures to include a reference to CAPA cancellation and to clarify the duties of the individual in charge of a CAPA to review the (b)(4) for the status of all open CAPAs. Training records on the updated procedure were provided for review. However, your firm failed to perform a retrospective review of CAPAs to ensure they are properly documented according to its approved procedures.
U.S. 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 III devices to which the Quality System regulation deviations are reasonably related will not be approved until the violations 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, including 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 (which must address systemic problems) 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. Please provide a translation of documentation not in English to facilitate our review. We will notify you regarding the adequacy of your firm’s response(s) 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 #443502 when replying. If you have any questions about the contents of this letter, please contact: Daniel Walter, Chief, Foreign Enforcement Branch at 301-796-5587 or 301-847-8139 (fax).
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 Inspectional 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.
Steven D. Silverman
Office of Compliance
Center for Devices and
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