Inspections, Compliance, Enforcement, and Criminal Investigations

Encompas Unlimited, Inc. 2/20/15

  

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 

 

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w/ DELIVERY CONFIRMATION
 
 
WARNING LETTER
FLA-15-16
February 20, 2015
 
 
Mary E. Flynn
President
Encompas Unlimited, Inc.
2219 Whitefield Park 
Sarasota, FL 34243
 
Dear Ms. Flynn:
 
During an inspection of your firm located in Sarasota, FL on November 10-18, 2014, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the 50 Endo Scrub, Adult Best Bite Block, Atypia Upper Endoscopy Headrest and an Endoscopy Wedge. 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 are 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 responses from Marybeth D. Flynn, Vice President dated December 2, 2014 and December 5, 2014 concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), 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 adequately establish and maintain procedures for implementing corrective and preventive actions (CAPA), as required by 21 CFR 820.100(a). For example:
 
a.    Your current CAPA procedure does not define requirements to verify and/or validate actions prior to implementation. Further, you have not verified and/or validated actions initiated on 09/09/14 related to additional receiving processing and in-process testing by your vendors used for the ST-94 bite block device.
 
b.    You have not implemented your current CAPA procedure to identify the potential causes of problems through investigation. You initiated a new (b)(4) on the (b)(4) of your SE-94 bite block device on 09/30/14. However; you did not determine the adequacy of these force specifications to demonstrate that the finished device conforms to your established specified requirements.
 
This observation is a repeated observation from the Form FDA 483, Inspectional Observations, issued to your firm on March 3, 2011 (Observation 1).
 
We reviewed your firm’s response and conclude that it is not adequate.  The basis for the (b)(4) specification load in your destructive testing is not included.  
 
2.      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). Specifically, your current customer complaint procedure does not include requirements to ensure that complaints are evaluated to determine whether the complaint represents an event which is required to be reported to the agency as a Medical Device Report.
 
The adequacy of your firm’s response cannot be determined at this time.  Your response did not include supporting documentation that the referenced procedures have been implemented. 
 
3.      Failure to establish procedures for receiving or finished product acceptance activities, as required by 21 CFR 820.80. Specifically, you have not defined adequate procedures for the receiving inspection covering the sponge component of your ES-50 Endo Scrub device. You did not establish that the sampling plan ensures a representative sample of the entire shipment received.
 
This observation is a repeated observation from the Form FDA 483, Inspectional Observations, issued to your firm on March 3, 2011 (Observation 3).
 
Your firm’s response to this observation appears to be adequate and your corrective actions will be verified during the next inspection. 
 
4.      Failure to adequately establish procedures to control product that does not conform to specified requirements, as required by 21 CFR 820.90(a). Specifically, you have not adequately defined procedures for the control of nonconforming ES-50 Endo Scrub devices during the receiving and in-process inspections.  For example: Your records for the in-process inspection of sponges used to manufacture devices during 07/18/03- 02/07/14 and during 02/21/14-10/30/14 do not list a description of the non-conformances identified for the products that were rejected.
 
The adequacy of your firm’s response cannot be determined at this time.  Your response did not include supporting documentation that the referenced procedures have been implemented. 
 
5.      Failure to establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements, as required by 21 CFR 820.50. Specifically, your current purchasing control procedure does not define the type and extent of control to be exercised over vendors and/or products based on the results of that evaluation.
 
We reviewed your firm’s response and conclude that it is not adequate. Your revised procedures do not define the type/extent of control based on ability of the suppliers to meet your requirements. The provided procedures appear to be focused on the qualification of your suppliers. Although it appears you have grandfathered your long time vendors, it does not appear that you have adequately established an approved supplier list or have established the criteria for your potential critical vendors.
 
6.      Failure to establish procedures to maintain device history records (DHRs) as required by 21 CFR 820.184. Specifically, you do not have written procedures to demonstrate the devices are manufactured in accordance with established specifications and current good manufacturing practices for your ES-50 Endo Scrub devices.  For example: Your records covering the in-process inspection and production of devices during 07/18/03- 02/07/14 and during 02/21/14-10/30/14 do not list lot numbers or manufacturing codes for these lots of finished devices.
 
This observation is a repeated observation from the Form FDA 483, Inspectional Observations, issued to your firm on March 3, 2011 (Observation 4).
 
We reviewed your firm’s response and conclude that it is not adequate. The procedures provided fail to require the documentation of retest/revaluation of nonconforming product after rework operations.
 
Our inspection also revealed that your firm’s devices are 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 respecting the device that is required by or under section 519 of the Act [21 U.S.C. § 360i], and 21 CFR Part 803 - Medical Device Reporting (MDR). Significant violations include, but are not limited to, the following:
 
Failure to develop, maintain and implement written MDR procedures, as required by 21 CFR 803.17. For example, your firm did not have a written MDR procedure for a standardized review process or procedure to determine when an event meets the MDR criteria, or for the documentation of the information that was evaluated to determine if an event was reportable.
 
This observation is a repeated observation from the Form FDA 483, Inspectional Observations, issued to your firm on March 3, 2011 (Observation 5).
 
We reviewed your firm’s response and conclude that it is not adequate. It does not appear that your MDR decision tree provides an adequate sequence of questions to make an appropriate MDR filing decision. Please refer to 21 CFR 803.10(c).
 
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 will take effect 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: http://www.fda.gov/ForIndustry/FDAeSubmitter/ucm107903.htm
 
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.
 
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 (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.
 
Please send your reply to the U.S. Food and Drug Administration, Attention: Andrea H. Norwood, Compliance Officer, 555 Winderley Place, Suite 200, Maitland, FL 32751. If you have any questions regarding any issues in this letter, please contact Ms. Norwood by telephone at (407) 475-4724. 
 
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,
/S/
Susan M. Turcovski
Director, Florida District

Page Last Updated: 03/16/2015
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