• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

  • Print
  • Share
  • E-mail

Section Contents Menu

Enforcement Actions

Sharn, Inc. 12/29/11

  

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 

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

WARNING LETTER
FLA-12-17
December 29, 2011
 


Bruce A. Tomlinson
President
Sharn, Inc.
4517 George Road, Suite 200
Tampa, FL 33634


Dear Mr. Tomlinson:


During an inspection of your firm located in Tampa, Florida, on August 10, 2011, through August 11, 2011, an investigator from the United States Food and Drug Administration (FDA) determined that your firm is a repacker and relabeler of Class I and Class II medical devices (e.g. Crystaline™ II and TempAlert™ II Temperature Indicators). 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 a response from Judy Tomlinson dated August 15, 2011, concerning our investigator's observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, 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. Failure to establish and maintain procedures for implementing corrective and preventative action (CAPA), as required by 21 CFR 820.100(a).


For example:
 

Your firm was unable to provide a copy of the CAPA procedures.


We reviewed your firm's response and conclude that it is not adequate. The Corrective and Preventative (CAPA) Procedures, dated 8/12/2011, are general in nature and did not address all of the requirements listed in 21 CFR 820.100(a). The procedures did not include provisions for analyzing quality audit reports or quality records to identify existing and potential causes of nonconforming product or other quality problems. In addition, the response did not provide evidence of projected implementation of the CAPA procedures.


2. Failure to establish and maintain adequate procedures for receiving, reviewing, and evaluating complaints by a formally designated unit to ensure that complaints are evaluated to determine whether the complaint represents an event which is required to be reported to FDA under part 803 of this chapter, Medical Device Reporting, as required by 21 CFR 820.198(a)(3).


For example:


Your firm provided a copy of the Handling Customer Complaints protocol, dated 05/13/2010, as an example of Sharn's complaint handling system. The protocol does not include a provision for determining how a complaint is evaluated to determine if the complaint is a reportable event under 21 CFR Part 803.


We reviewed your firm's response and conclude that it is not adequate. The response did not include evidence or documentation of a corrective action which included the review of the outstanding complaints using the revised protocol to determine if the complaints are reportable events. In addition, the response did not provide evidence of implementation of the revised protocol.


3. Failure to maintain adequate records of investigations by the formally designated unit identified in paragraph (a) of this section when an investigation is made, as required by 21 CFR 820.198(e).


For example:


According to the Handling Customer Complaints protocol, in the Procedures section, item number 5, the Complaint Report form must be signed and dated. A copy of the Complaint Report Form was provided (dated 06/02/2003). Your firm stated that the Complaint Report form should be signed when a complaint is closed. The investigator reviewed 38 complaints of which 32 had been closed. All of the closed complaint reports lacked the required signatures on the Complaint Report forms.


We reviewed your firm's response and conclude that it is not adequate. The response did not provide evidence that the 32 closed complaint reports have been signed. Also, in the revised Handling Customer Complaints protocol, dated 08/12/2011, in item number 6, under Procedure, your response did not explain what form is the official record form. In addition, evidence of implementation of the revised complaint handling procedures was not provided in the response.


4. Failure to establish and maintain adequate 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:


Your firm does not have a written purchasing control procedure to cover all received products. A copy of the "Purchasing Control Protocol for Product Which Is Not Within Acceptable Specification Range", dated 06/08/2001, was provided. This protocol pertains only to the liquid crystal product and does not address other products received by your firm.


We reviewed your firm's response and conclude that it is not adequate. The response did not address this violation. Although your response indicated that Sharn is committed to making each correction as soon as possible, documentation or evidence of the corrections and/or corrective actions for this violation was not provided.


5. Failure to establish and maintain adequate procedures for acceptance activities, as required by 21 CFR 820.80(a).


For example:


Your firm provided copies of the "Testing Procedure for the Crystaline™ II, and TempAlert™ II Temperature Indicators", dated 02/28/2005; and the "Receiving Product", dated 02/28/2005 as examples of Sharn's acceptance activities. There are no acceptance procedures for any of the other products received by your firm.


We reviewed your firm's response and conclude that it is not adequate. The response did not address this violation. Although your response indicated that Sharn is committed to making each correction as soon as possible, documentation or evidence of the corrections and/or corrective actions for this violation was not provided.


6. Failure to establish and maintain adequate procedures to control product that does not conform to specified requirements, as required by 21 CFR 820.90(a).


For example:


Your firm provided a copy of the "Non-Complaint Product" protocol, dated 06/08/2001, as an example of Sharn's nonconformance protocol. In line 1, your firm noted that "Sharn will analyze processes and work operation once every six months to identify existing or potential causes of non-conforming product or other quality products." This protocol does not address how products received by your firm will be analyzed for non-conformities.

 

We reviewed your firm's response and conclude that it is not adequate. The response did not address this violation. Although your response indicated that Sharn is committed to making each correction as soon as possible, documentation or evidence of the corrections and/or corrective actions for this violation was not provided.


7. Failure to establish and maintain adequate procedures to control all documents that are required by 21 CFR 820, as required by 21 CFR 820.40.


For example:


Your firm provided a copy of the "Document and Data Control" procedure, dated 04/08/2001, as an example of Sharn's document control process. The procedure does not include a provision for designating an individual to review documents for adequacy or a provision for designating an individual to approve documents for your firm.


We reviewed your firm's response and conclude that it is not adequate. The "Document and Data Control" procedure, dated 08/15/2011, is general in nature and did not address all of the requirements listed in 21 CFR 820.40. For example, with regards to change records, the procedure did not include provisions for describing the change, how the changed documents will be identified, and how the changed documents will be communicated to personnel. In addition, evidence of implementation of the revised "Document and Data Control" procedure was not provided in the response.


8. Failure to maintain device master records (DMR's), as required by 21 CFR 820.181.


For example:


Upon request, your firm indicated that it does not maintain a DMR.


We reviewed your firm's response and conclude that it is not adequate. The response did not address this violation. Although your response indicated that Sharn is committed to making each correction as soon as possible, documentation or evidence of the corrections and/or corrective actions for this violation was not provided.


9. Failure to maintain device history records (DHR's), as required by 21 CFR 820.184.


For example:


Upon request, your firm indicated that it has not established procedures for DHRs.


The response did not address this violation. Although your response indicated that Sharn is committed to making each correction as soon as possible, documentation or evidence of the corrections and/or corrective actions for this violation was not provided.


10. Failure to establish procedures for quality audits and conduct such audits to assure that the quality system is in compliance with established quality system requirements and to determine the effectiveness of the quality system, as required by 21 CFR 820.22.


For example:


Your firm stated that it does not have a procedure to conduct internal quality audits.


The response did not address this violation. Although your response indicated that Sharn is committed to making each correction as soon as possible, documentation or evidence of the corrections and/or corrective actions for this violation was not provided.


11. Failure to adequately review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency according to established procedures to ensure that the quality system satisfies the requirements of 21 CFR 820 and the manufacturer's established quality policy and objectives, as required by 21 CFR 820.20(c).


For example:


Your firm provided a copy of the "Management Review" protocol, dated 04/18/2001, as an example of Sharn's management review procedures. This protocol did not include provisions for appointing a management representative or for specifying the responsibilities of the management representative. In addition, the protocol did not include provisions for the review of quality audit results and other quality data or quality records that will be conducted by your firm.


The response did not address this violation. Although your response indicated that Sharn is committed to making each correction as soon as possible, documentation or evidence of the corrections and/or corrective actions for this violation was not provided.


Our inspection (also) revealed that your firm's Class I and Class II General Surgery and Anesthesia Products 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. 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 an MDR procedure to submit to the FDA investigator.


We reviewed your firm's response and conclude that it is not adequate. Your firm submitted an MDR protocol, "Medical Device Reporting (MDR) Procedures", dated 8/12/2011. The following deficiencies were noted:


Your firm's procedure fails to establish a process that provides for:
 

a. Timely and effective identification, communication, and evaluation of events that may be subject to MDR requirements. For example:


• The procedure does not include terms defined in 21 CFR 803.3 that it will use to make a determination of a reportable event. To facilitate the correct interpretation of reportable events and to assure the quality of MDR submissions, the procedure should include additional definitions for become aware; caused or contributed; malfunction; MDR reportable event; remedial action; and reasonably known found in 803.30(b); and reasonably suggests found in 803.20(c)(1).


• The procedure does not address evaluating events in which a device marketed by the firm may have caused or contributed to a death, as required by 21 CFR 803.50(a)(1).


• The procedure does not address evaluating events for the malfunction of a device or a similar device marketed by your firm that would be likely to cause or contribute to a death or serious injury if the malfunction were to recur, as required by 21 CFR 803.50(a)(2).


b. Standardized review process or procedure for determining when an event meets the criteria for reporting under this part. For example:


• The procedure contains the following statement on page 2:


"Sharn will consider the MDR closed when notified by the FDA that their investigation is closed".


This is an incorrect statement that may lead to your firm's failure to conduct an investigation of an event and evaluate the cause of an event, as required 21 CFR 803.50(b)(3).


c. Timely submission of complete medical device reports including:


• The procedure does not state the required timeframe to submit supplemental or follow-up reports, as required by 21 CFR 803.58. The omission of the 1 month timeframe to report a supplemental or follow-up report may lead to your firm's failure to meet the requirements under this section of the MDR regulation.


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.


Your firm's response should be sent to: Winston R. Alejo, Compliance Officer, 555 Winderley Place, Suite 200, Maitland, Florida, 32751. Refer to the Unique Identification Number (CMS case# 226554) when replying. If you have any questions about the contents of this letter, please contact: Mr. Alejo at (407) 475-4731 or fax--(407) 475-4769.


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/
Emma R. Singleton

Director, Florida District
7