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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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King Systems Corp. 9/30/13

  

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

Public Health Service
Food and Drug Administration
 Detroit District
300 River Place
Suite 5900
Detroit, MI 48207
Telephone: 313-393-8100
FAX: 313-393-8139 

 

WARNING LETTER
2013-DET-24
 
 
September 30, 2013
 
VIA UPS
 
Mr. Stephen P. Davis, CEO
King Systems Corp
15011 Herriman Blvd.
Noblesville, Indiana 46060-4253
 
Dear Mr. Davis:
 
During an inspection of your firm located in Noblesville, Indiana, on July 31 through August 14, 2013, an Investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the King Flex 2, King F2, King PedF2, and King F Breathing Circuits; and the King LT-D and King LTS-D Oropharyngeal Airways. 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 any function of the body.
 
This inspection revealed that the King Flex 2, King F2, King PedF2, and King F Breathing Circuits 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 your firm’s responses, dated September 4, 2013, 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 validate, with a high degree of assurance and approve according to established procedures, a manufacturing process that cannot be fully verified by subsequent inspection and testing, to ensure the process will continue to meet specifications as required by 21 CFR 820.75(a).
 
For example:
 
a.   Your firm’s (b)(4) have not been validated to ensure that the process will continue to meet predetermined specifications.  These (b)(4) are used to produce tubing to be assembled into the King Flex 2, King F2, King PedF2, and King F Breathing Circuits that are utilized to administer medical and/or anesthetic gases to a patient during anesthesia for inhalation or respiratory care inhalation.  
 
b.    Your validation of the Flex 2 Assembly Automation System did not adequately determine if leak testing performed on finished product was capable of detecting leaks of varying sizes in various locations in the tubing of a collapsed circuit for leak testing performed in Operational Qualifications VAL-OQ-03-001 and VAL-OQ-03-002. Your process challenge devices included circuits with leaks due to "holes or varying sizes in order to provide a range of leak rates that are over the limit of 10, as measured (when collapsed) on (b)(4)" however, the size and locations of the holes were not documented to ensure that a representative number of holes were placed into the peaks and valleys of the tubing, and places in between. Additionally, your firm has not conducted any studies on leak testing collapsed tubing to ensure that holes of various sizes and locations can be accurately and precisely measured.
 
Though the process validation activities included in your firm’s response, dated September 4, 2013, appear to include the elements that will enable your firm to achieve compliance with 21 CFR 820.75(a), your response is not adequate as the indicated timeline of (b)(4) for completion of validation activities for your extrusion process is unacceptable. Additionally, your response did not indicate your firm’s timeline for completion of validation activities for your remaining product lines.
 
2.    Failure to establish and maintain procedures to ensure that specified requirements for in-process product are met as required by 21 CFR 820.80(c). 
 
For example: Your firm’s in-process occlusion testing of coaxial pediatric breathing circuits is not performed in a manner that would detect nonconforming product and prevent it from being distributed. On August 2, 2013, despite your firm’s Standard Work Instruction 30-024-001-01 (effective October 29, 2012) stating, for occlusion testing "(b)(4)" the FDA Investigator observed an employee holding coaxial pediatric breathing circuits up to the occlusion tester on production line (b)(4) for less than one second which did not allow stabilization of the tester reading. In approximately 3 minutes, the FDA Investigator observed the employee testing approximately twenty-five (25) circuits in this manner. 
 
Your firm’s response, dated September 4, 2013, cannot be evaluated as you acknowledge that corrective actions have not been fully implemented. Additionally, your response indicates you anticipate implementing all corrective actions by (b)(4).
 
3.    Your firm’s Complaint Handling Procedure, SOP 35-012-09 dated September 19, 2011, fails to include procedures for evaluating complaints to determine when an investigation is necessary, as required by 21 CFR 820.198(b). The procedure also fails to include procedures for review, evaluation and investigation of all complaints involving the possible failure of a device, labeling, or packaging to meet any of its specifications, unless such investigation has already been performed, as required by 21 CFR 820.198(c). Of twenty-three (23) complaint files reviewed during the inspection, 5 complaints relating to a possible failure of a device, labeling, or packaging to meet its specifications were not investigated. For example:
 
a.    Complaint Inquiry 018252 (dated August 23, 2012) stated the customer received the King Systems Universal Flex 2 Breathing Circuit labeled as latex free however, the devices contained latex. This complaint was not investigated despite it involving a failure of device labeling to meet its specifications. Investigation of this complaint during the current FDA inspection resulted in a Class II recall.   
 
b.    Complaint 018899 (dated December 14, 2012) stated the customer ordered King Oropharyngeal Airway (KLTSD415, size 5) however received the Oropharyngeal Airway (KLTSD414, size 4). The outside labeling indicated KLTSD415 (size 5) however, KLTSD414 (size 4) airways were inside the case. This complaint was not investigated despite it involving a failure of device labeling to meet its specifications. Investigation of this complaint during the current FDA inspection resulted in a Class II recall.     
 
c.    Complaint inquiry 018046 (dated July 16, 2013) stated “the HME is splitting in half”. This complaint was not investigated despite it involving the possible failure of device to meet its specifications. 
 
Your firm’s response, dated September 4, 2013, cannot be evaluated as you acknowledge that corrective actions have not been fully implemented. Additionally, your response indicates you anticipate implementing all corrective actions by (b)(4).
 
4.    Failure to establish and maintain procedures for the control of storage areas and stock rooms for product to prevent mix-ups, damage, contamination, or other adverse effects pending use or distribution, and to ensure that no obsolete, rejected, or deteriorated product is used or distributed, as required by 21 CFR 820.150(a). 
 
Raw materials in your firm’s warehouse are not stored in a manner that would prevent mix-ups. For example:
 
a.    When warehouse bin locations (b)(4) were reviewed for inventory accuracy, the FDA Investigator observed: 
 
i.    Bin (b)(4) contained (b)(4) cases of Cushion 4 (Part 838-222, Lot I15N4) which were not listed on your Physical lnventory Count Sheets. Also, the count sheet indicated Bin (b)(4) contained (b)(4) units of Crown 3 (Part 836-028, Lot I1CDC) however; this component was not present in the bin.
 
ii.    Bin (b)(4) contained (b)(4) cases of Crown 3 (Part 836-028, Lot I1CDC) for a total of (b)(4) units however; this part was not listed on the Physical Inventory Count Sheets for this bin.
 
Your firm’s response, dated September 4, 2013, cannot be evaluated as you acknowledge that corrective actions have not been fully implemented. Additionally, your response indicates you anticipate implementing all corrective actions by (b)(4). Your response also states your firm will implement a real-time inventory management system that utilizes bar codes and scanners by (b)(4).
 
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 device have been corrected.
 
We request that you submit your revised plan for corrective actions based on this correspondence and include an update of corrective action implementation for the portion of your plan that does not require revision. Please submit your firm’s response in writing, within fifteen business days from the date you receive this letter, to the following address:
 
                        Food and Drug Administration
                        Detroit District Office
                        300 River Place, Suite 5900
                        Detroit, Michigan 48207
 
If you have any questions about the content of this letter, please contact: CDR Kimberly Martin at (317) 226-6500 ext. 116.
 
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 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/                                                                               
Glenn T. Bass
District Director
Detroit District Office