Inspections, Compliance, Enforcement, and Criminal Investigations

Okamoto Industries, Inc. 11/23/15

  

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

Public Health Service
Food and Drug Administration
 10903 New Hampshire Avenue
White Oak Building 66
Silver Spring, MD 20993

 

WARNING LETTER
NOV 23, 2015 
 
 
VIA UNITED PARCEL SERVICE
 
Kenji Tanaka, Ph.D.
Plant Manager
Okamoto Industries, Inc.
No. 1, Nishiyama-Itabashi-Cho
Ryugasaki-Shi, Ibaraki-Prefecture 301-0801
Japan
 
Dear Dr. Tanaka:
 
During an inspection of your firm, located in Ryugasaki-Shi, Ibaraki-Prefecture, Japan, on July 20, 2015, through July 23, 2015, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures natural rubber latex condoms. 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.
  
Our 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 August 12, 2015, 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. Your firm’s responses, dated September 18, 2015, and October 20, 2015, to the Form FDA 483 (FDA 483) were not reviewed because they were not received within fifteen business days of issuance of the FDA 483. These responses will be evaluated along with any other written material provided in response to the violations cited in this Warning Letter.  These violations include, but are not limited to, the following:
 
1.     Failure to establish and maintain design validation procedures to ensure that devices conform to defined user needs and intended uses and shall include testing of production units under actual or simulated use conditions, as required by 21 CFR 820.30(g). For example:
a.     Your firm’s design control procedure, Document (b)(4), Version 4, does not require design validation to be performed on initial production units, lots, or batches, or their equivalents to ensure that the resulting device conforms to defined user needs and intended uses.
b.     Your firm has manufactured and distributed the Okamoto Ultra-Thin Male Natural Latex Condom (JN-N42) since the year 2010; however, your firm has not validated the design of JN-N42 to ensure that the defined user needs and intended uses are met. 
 
The adequacy of your firm’s response cannot be determined at this time. Your firm’s response states that your firm plans to revise the design control procedure to include the requirement for conducting design validation on the initial lot, and perform design validation for JN-N42. Also, your firm’s response states your firm plans to conduct a retrospective review of design files to ensure that the design validations for other devices are adequately established.  However, documentation of implementation of the proposed corrective actions was not included in your firm’s August 12, 2015, response.
  
2.     Failure to ensure that, when the results of a process cannot be fully verified by subsequent inspection and test, the process shall be validated with a high degree of assurance and approved according to established procedure, as required by 21 CFR 820.75(a). For example, your firm uses (b)(4) mixing tanks to mix and produce (b)(4) compounded latex to manufacture LS-Type condoms.  However, your firm has not validated the compounding or mixing processes using the (b)(4) mixing tanks.
 
The adequacy of your firm’s response cannot be determined at this time. Your firm’s response states your firm plans to revise the process validation procedure, “Document # C-QP-0012,” and perform revalidation of the (b)(4) compound mixing process. Additionally, your firm’s response states your firm plans to review of other processes that may require a validation.  However, documentation of implementation of the proposed corrective actions was not included in your firm’s August 12, 2015, response.
  
3.     Failure to establish and maintain procedures for implementing corrective and preventive action (CAPA), as required by 21 CFR 820.100(a). For example, your firm’s CAPA procedure, “Document (b)(4),” version 10, does not include a requirement for analyzing quality data to identify existing and potential causes of nonconforming product, or other quality problems, using appropriate statistical methodology where necessary.  Additionally, your firm has not analyzed quality data to identify existing and potential causes of nonconforming product, or other quality problems.
 
The adequacy of your firm’s response cannot be determined at this time. The response indicates that the CAPA procedure will be revised to state that CAPA initiation will be additionally based on quality data analysis.  Also, the response states that personnel training will be conducted for the revised CAPA procedure. However, documentation of implementation of the proposed corrective actions was not included in your firm’s August 12, 2015, response.
 
4.     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). For example, a dirty rag was used to control the water-like fluid leakage at a pipe joint between (b)(4).
 
The adequacy of your firm’s response cannot be determined at this time. Your firm’s response indicates that a reassessment of the pipes under the walls will be performed to address defects as necessary. The response also stated that you will establish a system for timely check and maintenance of pipes to prevent identified defects from reoccurring.  However, documentation of implementation of the proposed corrective actions was not included in your firm’s August 12, 2015, response.
 
5.     Failure to develop, conduct, control, and monitor production processes to ensure that a device conforms to its specifications, as required by 21 CFR 820.70(a). For example, your firm’s production work standard, “Document (b)(4),” requires (b)(4) by batch weight of (b)(4) solutionto be used in the manufacturing of (b)(4) compounded latex for LS-Type condoms. However, your firm’s records indicate that (b)(4) by batch weight of a (b)(4) solution was used for the (b)(4) compounded latex lot #1675N2UC.
 
The adequacy of your firm’s response cannot be determined at this time. The response indicates that the use of (b)(4) batch weight of (b)(4) solution was correct. Your firm’s response states that your firm uses (b)(4) batch weight of (b)(4) solution for other products, and this number was inadvertently used in the product work standard for the (b)(4) compounded latex.  Your firm’s response included the revised the product work standard, “Document (b)(4),” to reflect the correct value, and a record of personnel training.  Your firm’s response indicated that a retrospective review of Device Master Records will be performed.  However, documentation of implementation of the proposed corrective actions was not included in your firm’s August 12, 2015, response.
  
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.
  
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. We will notify you regarding the adequacy of your firm’s response and the need to re-inspect your firm’s facility to verify that the appropriate corrections and/or corrective actions have been made.
  
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 3523, 10903 New Hampshire Ave., Silver Spring, MD 20993. Refer to CMS # 480261 when replying. If you have any questions about the contents of this letter, please contact LT David Dar, Acting Chief, Foreign Enforcement Branch, at feb@fda.hhs.gov (email) or +1(240)402-4020 (telephone).
  
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,
/S/                                                           
CAPT Sean M. Boyd, MPH, USPHS
Acting Director
Office of Compliance
Center for Devices and Radiological Health
 
 
cc:
Hisayuki Naito
U.S. Agent
Okamoto U.S.A., Inc.
18 King Street
Stratford, Connecticut 06615

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