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  5. Unomedical s.r.o. - 06/24/2014
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Unomedical s.r.o.

Unomedical s.r.o.

United States

Issuing Office:
Center for Devices and Radiological Health

United States


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

Public Health Service
Food and Drug Administration
 10903 New Hampshire Avenue
Silver Spring, MD 20993 


JUNE 24, 2014 
Niels Frost-Nielsen
Vice President
Unomedical s.r.o.
Priemyselny Park 3
071 01 Michalovce
Dear Mr. Frost-Nielsen:
During an inspection of your firm located in Michalovce, Slovakia, on February 3, 2014, through February 6, 2014, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures urology catheters. 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 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 February 26, 2014, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of 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 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, procedures were not established and maintained for monitoring and control of catheter manufacturing. Your firm had no documentation of process control parameters during production to allow assessment of whether your firm’s validated manufacturing process was under control. 
The adequacy of the response dated February 26, 2014, cannot be determined at this time.  CAPA 327789 was opened and a correction, “check of machine parameters,” was added to the final review of the device history record. Your firm supplied a draft of (b)(4) procedure that will be implemented to determine critical process parameters.  A gap analysis, covering all (b)(4) processes, will also be performed to determine any gaps in all existing process instructions. However, neither the implemented validation procedure nor the gap analyses were provided for our review.
2.    Failure to establish and maintain procedures to control environmental conditions that could reasonably be expected to have an adverse effect on product quality and failure to periodically inspect environmental control systems to verify that the system is adequate and functioning properly, as required by 21 CFR 820.70(c). Specifically:
Your firm (b)(4) in an (b)(4), which was observed to have several test failures for air particle counts, (b)(4) bacterial counts, and finger tests:  
a.    Your firm's hygiene report for July 2013 shows several failures in the air particle count in (b)(4) and high levels of bacteria in the (b)(4).
b.    Your firm's hygiene report for December 2013- January 2014 shows failures in "(b)(4)" and "(b)(4)."  The particle count also exceeded the action limit.  The report conclusion states, "(b)(4).  New CAPA is opened.  Microbiological test is compliance with [a] request of (b)(4) for (b)(4) will be re-tested in February." Your firm failed to provide information that this CAPA has been resolved; therefore, your firm appears to be manufacturing in a controlled area in which there is no assurance that the controls are being met.
The adequacy of the response dated February 26, 2014, cannot be determined at this time.  Your firm stated that it will perform a Hazard Analysis of Critical Control Points (HACCP) to determine controls required in all areas used for sterile product manufacturing and update procedures accordingly. The review of the C4 processing area is to be completed by March 31, 2014. In addition your firm stated that its (b)(4), will be revised to include instructions on escalation to the nonconformance and CAPA processes, warning limits based on historical trends as appropriate, and instructions for immediate risk assessment and corrections. Your firm stated that this revised procedure will be implemented by April 30, 2014. However, we have not received any of this documentation for our review.
3.    Failure to review and evaluate the process and perform revalidation, where appropriate, when changes or process deviations occur and to document these activities, as required by 21 CFR 820.75(c).
For example, your firm did not follow its procedures for conducting revalidation of its sterilization process.  Your firm's procedure, (b)(4), dated 16-May-2012, requires a reduced (b)(4) study at least every (b)(4).  Your firm conducted the last revalidation in July 2010.
The response dated February 26, 2014, is inadequate.  Your firm estimated that the full implementation of the new validated sterilization process through its change control process would be completed by March 31, 2014. However, we have not received any further information for review.
4.    Failure to define the type and extent of control to be exercised over the product, services, suppliers, contractors, and consultants, based on the evaluation results, as required by 21 CFR 820.50(a)(2).
For example, your firm’s (b)(4), dated 04-July-2012, requires (b)(4) evaluation for all QA critical suppliers in the approved supplier list.  Also, section 5.9 of the procedure states, (b)(4)  However, your firm did not audit its (b)(4), per its procedure after this supplier received a 2012 supplier grade of 1.5.
The adequacy of the response dated February 26, 2014, cannot be determined at this time.  Your firm opened CAPA 327792 and determined that the root cause for not auditing your supplier was that there was no rationale documented on the supplier evaluation form.  Your firm stated that it will revise its Supplier Evaluation procedure to define responsibilities for assessing the need for an audit and for documenting the rationale.  Your firm also stated that training of affected individuals will be performed, and supplier evaluation and audit status will be included in Management Review.  An audit of the referenced supplier was scheduled for March 7, 2014. However, the results of these activities were not available for our review.
5.    Failure to establish and maintain  procedures to ensure that sampling methods are adequate for their intended use and to ensure that when changes occur the sampling plans are reviewed, as required by 21 CFR 820.250(b).
Your firm did not provide a statistical rationale to justify the sampling method for incoming acceptance activities of raw materials.  For example:
a.    On or around January 23, 2014, your firm accepted (b)(4) used in manufacture of (b)(4), after sampling only (b)(4) piece.
b.    On or around January 29, 2014, your firm accepted the delivery of (b)(4) of (b)(4) and conducted (b)(4) with no justification for the sample size.
The adequacy of the response dated February 26, 2014, cannot be determined at this time.  CAPA 327793 was opened and material specifications were updated to include statistically-based sampling plans for (b)(4) and “(b)(4) Your firm stated that all material specifications will be reviewed and, where a sampling plan is required, (b)(4) or another valid statistical rationale will be used in the sampling instructions.  Procedures for incoming inspection and statistical techniques are also to be revised accordingly.  Your firm stated that implementation of these revised procedures should be completed by March 31, 2014. However, the results of these activities were not available for our review.
U.S. 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 deviations are reasonably related will not be approved until the violations 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, including 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 action (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.  Please provide a translation of documentation not in English to facilitate our review.
Your firm’s response should be sent to: Food and Drug Administration, Center for Devices and Radiological Health, Office of Compliance, Field Inspections Support Branch, White Oak Building 66, Rm 2609, 10903 New Hampshire Ave., Silver Spring, MD 20993. Refer to the Unique Identification Number (CMS Case # 428938) when replying. If you have any questions about the contents of this letter, please contact: Daniel Walter, Chief, Foreign Enforcement Branch, at (301) 796-5587 (phone) or (301) 847-8136 (fax).
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 yours,
Steven D. Silverman
Office of Compliance
Center for Devices and
Radiological Health

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