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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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RGI Medical Manufacturing, Inc.

   

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

Public Health Service
Food and Drug Administration
 

555 Winderley Pl., Ste. 200

Maitland, FL 32751

CERTIFIED MAIL 
RETURN RECEIPT REQUESTED


WARNING LETTER

FLA 09-03


December 8, 2008


Mr. Darren F. Kahn, Managing Director
RGI Medical Manufacturing, Inc.
2321 NW 66th Court
Gainesville, FL 32653-1653


Dear Mr. Kahn:


During an inspection of your firm located in Gainesville, Florida on September 8 to 11, 2008, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures I.V. Administration and Extension Set, class II devices in accordance with Title 21, Code of Federal Regulations (C.F.R.), section 880.5440. 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 (CGMP) requirements of the Quality System regulation (QS) found at 21 C.F.R. Part 820. We received a response from Mark J. Kahn, Quality Control Manager, dated October 10, 2008, concerning our investigator's observations noted on the Form FDA 483, List of Inspectional Observations that 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 adequately ensure that, where the results of a process cannot be fully verified by subsequent inspection and test, the process is validated with a high degree of assurance and approved according to established procedures, as required by 21 C.F.R. § 820.75(a). For
example,


A. Your firm failed to validate the sealing process for the pouch used to package the Coil-IV and Extension Set medical devices.

 

We have reviewed your response and have concluded that we need additional information in order to evaluate the adequacy of your proposed corrective actions. our response includes the validation protocol but does not include the results of the validation. Therefore, its adequacy cannot be assessed. Please include the results of the validation with your response to this letter.


B. Your firm failed to complete ethylene oxide (EO) residue testing of the Coil-IV or the Extension set medical devices, which are used for contact with the bloodstream, but did perform EO residue testing of the Endoscope Holder Pneumatic Air Tubing, which is not intended for patient contact. 


We have reviewed your response and have concluded that we need additional information in order to evaluate the adequacy of your proposed corrective actions. Although your actions appear to be adequate, we are unable to make this finding because you did not include the results of your EO residual testing. Please include the results of your testing with your response to this letter. 

 

C. Your firm's Process Validation procedure requires (b)(4) to be included in validation studies, but you do not have documentation to show that this will adequately demonstrate the consistency of the subject process. 

 

We have reviewed your response and have concluded that it is inadequate because, although you include an Inspection Sampling Program procedure, you do not provide an  updated Process Validation procedure. Please include a copy of this procedure with your response to this letter. 

 

D. Your firm's sterilization validation is inadequate in that:

 

i. our firm's protocol states (b)(4) which requires at least (b)(4) for a sterilizer chamber with a size of (b)(4) In 2006, only (b)(4) were used in your empty chamber study for chamber B at set point (b)(4)


We have reviewed your response and have concluded that it is inadequate because you simply refer FDA to a letter from (b)(4) Your firm is ultimately responsible for the sterilization validation whether it is performed by your firm or contracted out to a third-party. 

 

ii. Your firm's empty chamber studies consistently demonstrate that the first 30 minutes of the EO exposure phase do not meet the (b)(4) requirement that temperature be within (b)(4) of the set point. 

 

We have reviewed your response and have concluded that it is inadequate because your firm has not provide us with data from at least (b)(4) within the recommended tolerance of (b)(4) in accordance with (b)(4) requirements. Please include this data with your response to this letter. 

 

iii. Your firm failed to complete a heat distribution study in order to meet the (b)(4) requirement that throughout the exposure time the sterilization load should attain the minimum specified temperature and the temperature range across the product load should be less than or equal to (b)(4) at any given time during the sterilant exposure. 

 

We have reviewed your response and have concluded that we need additional information in order to evaluate the adequacy of your proposed corrective actions. please include a copy of temperature distribution study performed by (b)(4) with your response to this letter. 

 

iv. Your firm did not include a process challenge device in your original validation on 2006. (b)(4) biological indicators (BIs) were placed in between (b)(4) and (b)(4) of Extension Set in only one half cycle in June 2008. 

 

We have reviewed your response and have concluded that it is inadequate because you do not explain why a process challenge device was not included in your original validation in 2006 in order to assure that the BIs inside the device would indicate a Sterility Assurance Level (SAL) of 10-6. 

 

v. your firm failed to assure that sterilization does not affect the Coil-IV product and your testing of post-sterilization Extension Sets did not include measurements of all specifications, including outer diameter, inner diameter, and length. 

 

We have reviewed your response and have concluded that we need additional information in order to evaluate the adequacy of your proposed corrective actions. FDA disagrees with your conclusion that "the risk of changes to outer diameter, inner diameter and length of the Coil-IV and Extension Sets are low since materials are made from (b)(4) that are (b)(4). Thus, we must review the results of your post-sterilization validation testing. Please include a copy of your test results with your response to this letter.  

 

2. Failure to fully document employee training, as required by 21 C.F.R. § 820.25(b). Specifically, your firm's qualification of employees who perform the (b)(4) process is inadequate in that:

 

A. Your firm did not complete training slips demonstrating qualification on various (b)(4) processes for five employees. 

 

We have reviewed your response and have concluded that we need additional information in order to evaluate the adequacy of your proposed corrective actions. You state that "all training records are up to date," but you have not provided documentation showing that the five individuals received training on the referenced (b)(4) processes. Please provide this documentation with your response to this letter. 

 

B. The Training/Manufacturing slips completed by your firm for qualification of employees include only visual inspection of employees include only visual inspection of (b)(4) and do not provide for non-visual inspection testing (such as pull test of the (b)(4) units, etc).


We have reviewed your response and have concluded that we need additional information in order to evaluate the adequacy of your proposed corrective actions. You have not provided documentation showing that non-visual inspection testing was required for qualification of employees. Please provide this documentation with your response to this letter.


C. Your firm's qualification (training) procedure fails to require a minimum number of successful operations to confirm that the employee can consistently complete the (b)(4) process per specifications.


We have reviewed your response and have concluded that it is inadequate because in addition to requiring numerous successful operations, you have indicated that you will also accept various numbers of rejects during performance of the qualification procedure. The goal of qualification of employees, i.e., to document that they can complete the (b)(4) process consistently in accordance with specifications, is invalidated by your acceptance of various numbers of rejects during performance of the qualification procedure. 


D. Your firm's retraining (re-qualification) of employees includes only a review of the written procedure and does not require actual demonstration of adequate manual bonding by the employees. 

 

We have reviewed your response and have concluded that we need additional information in order to evaluate the adequacy of your proposed corrective actions. You indicate that you now require retraining and that it includes a "demonstration review of work step" and "physical test when applicable," but you do not define "applicable" nor do you specify what training protocol will be used for the retraining. Please provide a definition and a training protocol, or reference to a protocol you have previously provided to FDA, with your response to this letter. 


3. Failure to establish and maintain adequate quality requirements that must be met by suppliers and contractors, as required by 21 C.F.R. 820.50(a). For example your Purchasing Control procedure is inadequate in that:


A. Your firm's Vendor Questionnaire fails to include questions concerning process validation, including questions regarding validation of the (b)(4) process used to produce the tubing in their I.V. lines, (b)(4) maintenance, or assurances that the tubing is made from (b)(4). In addition, your questionnaire asks only yes or no questions and does not provide for a review of the adequacy of the documents obtained from your vendors.


We have reviewed your response and have concluded that we need additional information in order to evaluate the adequacy of your proposed corrective actions. Although your actions appear to be adequate, we are unable to make this finding because you did not include the revised Vendor Questionnaire. Please include the questionnaire with your response to this letter.


B. Your firm receives Certification from your tubing supplier that required specifications for the tubing material are met, but no verification has been done of this Certification.


Your response to this observation appears to be adequate. We add, however, that your firm should verify the Certificates from your suppliers for the specifications of incoming devices and/or components that you determine to be significant, not just the (b)(4) of the tubing material.


C. Your firm receives a Certificate of Conformance from your supplier of (b)(4) but does not verify the Certificate.


Your response to this observation appears to be adequate. We add, however, that in your purchasing control of the (b)(4) supplier, your firm should be including some assurance that the process validation of molding is adequate.


4. Failure to establish procedures for quality audits and failure to conduct such audits to assure that the quality system is in compliance with the established quality system requiremeri.ts and to determine the effectiveness of the quality system, as required by 21 C.F.R. § 820.22. Specifically, you do not have any quality audit procedures for major areas such as purchasing control, process validation, design control, corrective and preventive action, Corrections & Removals, and Medical Device Reporting (MDR).


We have reviewed your response and have concluded that it is inadequate because the internal quality audit criteria you provided still do not include quality audit procedures for Corrections Removals or MDR.


5. Failure to establish and maintain a design history file (DHF) for each type of device; as required by21 C.F.R. § 820.30(j). You lack DHFs for your Coil-IV and Extension Set medical devices, including but not limited to documentation of biocompatibility testing.


We have reviewed your response and have concluded that we need additional information in order to evaluate the adequacy of your proposed corrective actions. While we understand from your response that you are presently generating DFEs for your devices, you have not provided any documentation for FDA to review. Please include any documentation of completed testing with your response to this letter.


You 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 FDA without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties. Also, federal agencies are advised of the issuance of all 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. 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 (15) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrective action you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.


Your response should be sent to Brant Schroeder, Compliance Officer, Food and Drug Administration, 555 Winderley Place, Suite 200, Maitland, Florida 32751, (407) 475-4763.


Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, Form FDA 483 (FDA 483), issued at the closeout of the inspection may be symptomatic of serious problems in your firm's manufacturing and quality assurance systems. You should investigate and determine the causes of the violations, and take prompt actions to correct the violations and to bring your products into compliance.


Sincerely,

/S/
Emma Singleton
Director, Florida District