Inspections, Compliance, Enforcement, and Criminal Investigations

Stat Medical Devices, Inc. 7/23/15

  

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

Public Health Service
Food and Drug Administration
 
Florida District
555 Winderley Place, Suite 200
Maitland, Florida 32751
Telephone: 407-475-4700
Fax: 407-475-4770 

 

VIA UPS NEXT DAY AIR
w/ DELIVERY CONFIRMATION
 
WARNING LETTER
FLA-15-29
July 23, 2015
Steven Schraga
President
Stat Medical Devices, Inc.
2056 NE 153rd Street
N. Miami Beach, FL 33162-6020 U.S.A.
 
 
Dear Mr. Schraga:
 
During an inspection of your firm located in North Miami Beach, Florida on February 18, 2015 through February 20, 2015, an investigator from the United States Food and Drug Administration (FDA) determined that you are a specification developer of Blood Lancets, including the STAT Comfort Thins/Sterile Lancets; the STAT Lite & Ultimate Lancing Devices; the STAT Pedi-Let/Infant Heel–Blade; Blood Sampling Devices; and the STAT Auto/Clinical Safety Lancets.  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 is intended 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 March 12, 2015, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, which was issued to you. 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 all activities required under section 21 CFR 820.100, and their results are documented, as required by 21 CFR 820.100(b). For example, CAR #14-013, CAR #14-015, and CAR #14-016 were opened for lancing device nonconformances involving needle sticks, needles falling out, and submissions of malfunction MDRs, respectively. In Section C of each of the CARs, a “Satisfactory” response is recorded. Your firm’s Corrective and Preventive Action procedure, SOP 8.5-1, Rev. 12, Step 9, requires a satisfactory or unsatisfactory result be recorded after determining a Corrective Action actually removes the deficiency (Steps 10) and the Preventive Action will prevent occurrence of an undesirable event (Step 11). However,
 
a)      Your firm’s QA/RA Manager confirmed to the FDA investigator that the CARs were in the “Analysis” phase of DMAIC [Define, Measure, Analysis, Improve, and Check] process. Specifically, the CARs lack documentation of Root Cause, Impact on Material and/or Finished Device, and Corrective or Preventive Action under Section B, as required by your firm’s procedure, SOP 8.5-1, Step 8, prior to recording a “Satisfactory” response.
 
b)      The CARs do not include a Corrective Action or Preventive Action under Section B of the CAR, as required by your firm’s procedure, SOP 8.5-1, Steps 10-11. The CARs only report that “Any potential improvements from the DMAIC process will be implemented as Preventive Action(s).”
 
c)      The CARs do not include a method of determining effectiveness in Section C of the CARs, as required by your firm’s procedure, SOP 8.5-1, Steps 9 - 11.
 
We reviewed your firm’s response and conclude that it is not adequate. Your response states “Corrective and Preventive actions for this observation will be completed by 06/30/2015.” However, you did not provide supporting evidence that the referenced corrections and planned courses of action have been adequately implemented. 
 
2)      Although not listed on the FDA 483, further review by Compliance Branch revealed a failure to validate with a high degree of assurance, a process whose results cannot be fully verified by subsequent inspection and test, as required by 21 CFR 820.75(a) and 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,
 
a)   Your firm did not maintain documentation of sterilization validation to demonstrate that your current (b)(4) sterilization process is adequate and does not adversely affect the finished device and its packaging.
 
b)   Your firm did not maintain documentation of requalification assessments of your (b)(4) sterilization process at an established frequency.
 
Your firm’s response addressing (b)(4) sterilization processing states “There is no risk to sterilized lancet products since all lots have a sterilization certificate.” It is unclear how your firm has arrived at this conclusion when your firm does not maintain validation documentation and documentation of requalification assessments for all sterilization processes conducted by each of your firm’s foreign sub-contracted sterilization facilities, to ensure any “sterilization certificate” received by your firm is accurate and valid.
 
3)      Failure to adequately establish procedures to ensure that all purchased or otherwise received product and services conform to specified requirements, as required by 21 CFR 820.50. For example:
 
a)   Your firm did not implement procedure, SOP 7.4-1, Purchasing, Rev. No. 11, Section 7.0, Step 2, to verify that a vendor has been qualified and approved to provide a service, as evidenced by the vendor’s inclusion on the approved vendors list. Although (b)(4), foreign (b)(4) irradiation service providers ((b)(4)) appear on your firm’s approved vendors list, you did not maintain documentation verifying the vendors have been qualified and approved to provide their service. Your firm repeatedly stated to the FDA investigator that Stat Medical relies on their contract manufacturers to control (b)(4) irradiation processing of your firm’s blood lancets labeled as sterile.
 
b)   Your firm did not implement your “Qualification of Vendors and their Product or Service” procedure, SOP 7.4-3, Rev. No. 6, Section 7.0, Step 1. The procedure identifies sterilizers as a “critical vendor” and requires critical vendors to have a quality agreement. Further, your approved vendor list identifies (b)(4), foreign (b)(4) irradiation service providers ((b)(4)), that conduct the (b)(4) sterilization processing of your firm’s blood lancets with a “Risk Level” of “Critical vendor”. However, you did not maintain quality agreements with each of the (b)(4) irradiation service providers.
 
c)   Your firm did not maintain documentation of written consent provided to your foreign contract manufacturers ((b)(4)) for the sub-contracting of (b)(4) irradiation services for the conduct of the (b)(4) sterilization processing of your firm’s blood lancets, as required in your Quality Contracts (Supply Agreements) with the foreign contract manufacturers.
 
The adequacy of your response cannot be evaluated at this time. Your response states “Corrective and Preventive actions for this observation will be completed by 09/31/2015.” Your response did not provide supporting evidence that the referenced corrections and planned courses of action have been adequately implemented.
 
4)      Failure to establish and maintain adequate procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a). For example:
 
Your “Customer Complaints and Concerns” procedure, SOP 8.2-2, Rev. No. 6 is not adequate, in that:
 
a)      Section 7.0, Step 6 of the procedure requires an evaluation of each complaint, to determine whether it represents an event which is required to be reported to FDA under part 803, Medical Device Reporting (MDR), be documented. Your firm did not implement this part of your procedure, in that MDR determinations are not documented for all seven (7) complaints referenced in Complaint #14-047.
 
b)      The procedure did not include the requirement that records of investigations include any unique device identifier (UDI) or universal product code (UPC), and any other device identification(s) and control number(s) used, as required by 21 CFR 820.198(e)(3). For example, Complaint #14-047, received on October 17, 2014, reports your firm could not determine the lot numbers or purchase order numbers (for timeframe of distribution) for the six Stat Ultimate Lancing Devices relating to product quality nonconformances including caps falling off devices, devices not drawing blood when fired, and devices not griping lancets correctly.
 
c)      Your firm did not adequately implement Section 7.0, Step 10 of your complaint procedure, SOP 8.2-2, in that your firm did not provide objective evidence documenting that reviewing records spanning one year is sufficient when lot numbers and timeframes cannot be determined. The investigation of this complaint regarding caps falling off devices concludes all samples returned for loose cap exhibited wear of the snap rib, consistent with normal wear out (in excess of 4000 cycles). Your firm elected to review device history records (DHRs) spanning one (1) year when it was known snap rib wear at 3000 cycles would equate to a two (2) year span of DHRs.
   
We reviewed your firm’s response and conclude that it is not adequate. Your response states “Corrective and Preventive actions for this observation will be completed by 06/30/2015.”  However, you did not provide supporting evidence that the referenced corrections and planned courses of action have been adequately implemented.
 
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.
 
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 (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. Your firm’s response should be comprehensive and address all violations included in this Warning Letter.
 
Your response should be sent to:
 
Salvatore N. Randazzo
Compliance Officer
555 Winderley Place, Suite 200
Maitland, Florida, 32751 
 
Refer to the Unique CMS Identification Number 473754, when replying. If you have any questions about the content of this letter please contact: Salvatore N. Randazzo at (407) 475-4712.
 
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 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,
/S/
Susan M. Turcovski
Director, Florida District

Page Last Updated: 03/29/2018
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