Inspections, Compliance, Enforcement, and Criminal Investigations

Hindustan Syringes & Medical Devices Ltd. 5/13/16

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 10903 New Hampshire Avenue
Silver Spring, MD 20993 

 

WARNING LETTER
MAY 13, 2016 
 
VIA UNITED PARCEL SERVICE
 
Rajiv Nath
Joint Managing Director
Hindustan Syringes & Medical Devices Ltd.
174/Sector 25
Ballabgarh, Haryana 121004
India
 
Dear Mr. Nath:
 
During an inspection of your firm located in Ballabgarh, Haryana, India,on January 11, 2016, through January 14, 2016, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures catheters and disposable syringes. 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 January 21, 2016,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 that where the results of a process cannot be fully verified by subsequent inspection and test, 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, “Guidelines for Process\Equipment Validation”, QS 07 02 00 93, Rev. 2, dated March 24, 2015, requires operational qualification (OQ) to include a rationale for identifying critical parameters and demonstration at worst case conditions including justification for the number of runs. However, for the validation of the (b)(4), your firm has not conducted an OQ to establish a range of operating parameters.
 
We reviewed your firm’s response and conclude that it is not adequate.  Your firm’s response did not include an (b)(4) validation report for (b)(4). Additionally, your response did not include a review of other processes requiring validation to ensure they were validated in accordance with the requirements of 21 CFR 820.75 regulation.
 
2.    Failure to establish and maintain procedures for implementing corrective and preventive action (CAPA), as required by 21 CFR 820.100(a). For example, your firm's CAPA procedure, "C1.8 Measurement, Analysis and Improvement", QS 08 02 00 04, Rev. 2, dated December 8, 2014, is inadequate in that it does not contain the following elements:
 
a.  Requirements for verifying or validating CAPAs to ensure such actions are effective and do not adversely affect the finished device;
 
b.  Requirements for implementing and recording changes in methods and procedures needed to correct and prevent identified quality problems;
 
c.  Requirements for ensuring that information related to quality problems or nonconforming product is disseminated to those directly responsible for assuring the quality of such product or the prevention of such problems.
 
We reviewed your firm’s response and conclude that it is not adequate. The response included a revised CAPA procedure, "C1.8 Measurement, Analysis, and Improvement ", QS 08 02 00 04, Rev. 03, dated January 21, 2016, which includes the missing elements mentioned above. The response did not include a review of previous CAPAs to ensure they were processed in accordance with the requirements of 21 CFR 820.100 regulation. Also, your response did not include training records for the revised procedure.
 
3.    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 firm's complaint handling procedure, “Procedure for Handling Market Complaints, Post Market Surveillance & Vigilance System, QS 08 07 00 21, Rev. 07, dated October 16, 2014, does not ensure complaints are processed in a uniform and timely manner and complaints are evaluated for MDR reportability.
 
We reviewed your firm’s response and conclude that it is not adequate. The response did not include a revised complaint handling procedure to address the missing elements mentioned previously and the corresponding training records. Also, your firm’s response did not include a review of past complaints to ensure they were evaluated for MDR reportability.
 
4.    Failure to promptly review, evaluate, and investigate complaints that represent an event which must be reported to FDA under part 803, Medical Device Reporting, as required by 21 CFR 820.198(d).  For example, your firm’s complaint handling procedure, “Procedure for Handling Market Complaints, Post Market Surveillance & Vigilance System”, QS 08 07 00 21, Rev. 07, dated October 16, 2014,  has no requirements to ensure that MDR reportable events are maintained in a separate portion of the complaint files or otherwise clearly identified.
 
We reviewed your firm’s response and conclude that it is not adequate. The response did not include a revised complaint handling procedure to address the missing elements mentioned previously and the corresponding training records. 
  
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 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, Room 3540, 10903 New Hampshire Ave., Silver Spring, MD 20993. Refer to CMS case #494040 when replying. If you have any questions about the contents of this letter, please contact Daniel Walter, Chief, Foreign Enforcement Branch, at feb@fda.hhs.gov (email) or +1(240)402-4020 (telephone).
 
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. 
 
 
Sincerely yours,
/S/                                                                       
Robin W. Newman
Office Director
Office of Compliance
Center for Devices and
Radiological Health
 
 
Cc:
U.S. Agent
Sanjiv Kumar
Myco Medical Supplies, Inc.
158 Towerview Court
Cary, North Carolina 27513                  
 

 

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