- International Medsurg Connection, Inc.
- Issuing Office:
- Chicago District Office
| || |
Chicago District Office
550 W. Jackson Blvd., 15"' Floor
Chicago, IL 60661
Telephone: (312) 353-5863
Fax: (312) 596-4187
May 8, 2017
UPS NEXT DAY
Dr. Omi Bhati, President
International Medsurg Connection, Inc.
935 N Plum Grove Road Suite F
Schaumburg, IL 60173-4770
Dear Mr. Bhati:
During an inspection of International Medsurg Connection, Inc., located in Schaumburg, Illinois, conducted from August 16 through September 16, 2016, an investigator from the United States Food and Drug Administration (FDA) determined that your firm is specifications developer and manufacturer of hypodermic syringes intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. The device is used to inject fluids into, or withdraw fluids from, the body. 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 your 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. You may find the Act and FDA’s regulations through links in FDA’s home page at http://www.fda.gov/
Our investigator issued the Form FDA-483, Inspectional Observations, to you at the conclusion of the inspection on September 16, 2016. We received a response, dated September 29, 2016, from Manoj Gupta, Executive Vice President of Operations, concerning our investigator’s observations noted on the Form FDA 483 that 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. Procedures for finished device acceptance have not been adequately established, as required by 21 CFR 820.80(d).
A. For example, your firm does not have acceptance requirements to ensure (b)(4) of the hypodermic LL/LS syringes meet device specifications.
We reviewed your response, dated September 29, 2016 and find it is not adequate. The response states that the hypodermic syringes were sterilized using the validated (b)(4) however the response has not provided evidence to ensure the medical devices met specified sterilization parameters.
B. For example, Hypodermic LL/LS syringes were released without performing the required (b)(4) and (b)(4).
We reviewed your response, dated September 29, 2016 and find it is not adequate. Your response does not address the lots of hypodermic LL/LS syringes that were released without performing the required testing.
C. For example, your firm released hypodermic syringes without performing specified testing on the appropriate sample size for release.
We reviewed your response, dated September 29, 2016 and find it is not adequate. The response states that a new procedure, (b)(4) provides (b)(4). Your response does not address the scope of the affected product distributed. Specifically the product quality of the distributed medical devices and any potential impact of not performing final release testing on a representative sample of the lot to ensure product conforms to specified requirements.
2. Requirements that must be met by suppliers and contractors have not been adequately established, as required by 21 CFR 820.50(a).
For example, your firm does not include requirements for finished device acceptance of (b)(4) devices. The sterilization requirement were not included in the Hypodermic Syringe Specification and Inspection Procedures (b)(4). In addition, the investigator was provided incomplete sterilization records. These records were used by your firm to receive hypodermic LL/LS syringes.
We reviewed your response, dated September 29, 2016 and find it is not adequate. Your firm’s response has not addressed all lots of syringes affected by the omission of the requirement. The revision includes requirements that state the product shall be sterilized using a specified validation protocol. However, there still is no indication whether your supplier processed the devices using the specified conditions to ensure sterility.
According to the response, the specifications were also revised to include (b)(4). There is no indication what these specifications are since no further information was provided.
3. Procedures for corrective and preventive action have not been adequately established, as required by 21 CFR 820.100(a).
For example, your firm’s Corrective and Preventive Action Procedure (b)(4) fails to ensure that corrective and/or preventative actions are effective and do not adversely affect the finished device. During the inspection the investigator, identified 11 of 23 CAR/SCARs reviewed were implemented and were verified effective the same day.
We reviewed your response, dated September 29, 2016 and find it is not adequate. The response explains that some of the corrective /preventive actions were not verified for their effectiveness due to a lack of process for quality personnel to identify the CARs/ SCARs that required follow up on verification of their effectiveness. Your firm has not addressed the CAPAs that were deemed effective on the same day the corrective action was implemented. The CAPAs did not contain objective evidence for their closure as required by your firm’s CAPA procedure in section 2.7.3 that states corrective actions will be identified as effective when there is supporting objective evidence. No further information was provided.
Our inspection also revealed that the piston syringe is 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 regarding the devices that is required by or under Section 519 of the Act, 21 U.S.C. § 360i, and 21 CFR Part 803 - Medical Device Reporting. Significant deviations include, but are not limited to:
Failure of the firm to develop, maintain and implement MDR procedures, as required by 21 CFR 803.17. For example:
During the inspection, your firm acknowledged that it does not have an MDR procedure.
If your firm wishes to discuss the MDR related issues noted above, please contact the Reportability Review Team by email at ReportabilityReviewTeam@fda.hhs.gov
The eMDR Final Rule requiring manufacturers and importers to submit electronic Medical Device Reports (eMDRs) to FDA was published on February 13, 2014. The requirements of this final rule were effective on August 14, 2015. If your firm is not currently submitting reports electronically, we encourage you to visit the following web link for additional information about the electronic reporting requirements:
If your firm wishes to discuss MDR reportability criteria or to schedule further communications, it may contact the Reportability Review Team by email at ReportabilityReviewTeam@fda.hhs.gov.
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 III 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.
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.
Please notify this office in writing within fifteen (15) 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 written response should be sent to:
Rafael Padilla, Compliance Officer
Food & Drug Administration
550 W. Jackson Blvd., Suite 1500
Chicago, IL 60661
Refer to the Unique Identification Number (CMS Case #511426) when replying. If you have any questions about the content of this letter, please contact Mr. Padilla via email at Rafael.email@example.com
or by phone at (312) 596-4212.
Williams R. Weissinger
Chicago District Director