CHUNGDO PHARM. CO. LTD. 7/30/13
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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||10903 New Hampshire Avenue|
Silver Spring, MD 20993
July 30, 2013
VIA UNITED PARCEL SERVICE
ChungDo Pharm. Co. LTD.
202 HI-TECH VENTURE TOWN
Korea, Republic of (South) 200-160
Dear Shon Kim:
During an inspection of your firm located in Chuncheon, Republic of South Korea,on March 04, 2013 through March 07, 2013, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures Chemview-10TM Urinalysis Test Strips and Chemview-11. 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.
Your firm’s response dated March 21, 2013 to the Form FDA 483 (FDA 483) was not reviewed because it was not received within fifteen business days of issuance of the FDA 483. The response was received April 10, 2013. The response 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 procedures for implementing corrective and preventive action (CAPA) and to document all activities required under 21 CFR 820.100, as required by 21 CFR 820.100(a) and (b).
a. Your firm failed to investigate the cause and document the investigation, for CAPA #110717-1, regarding an oral complaint received from (b)(4); the CAPA record did not document the quantity of Nitrite 10T (Chemview-10) being incorrectly shipped on 7/12/2011, which was the nature of the complaint. You have indicated you received the oral complaint, but did not document it to ensure an adequate investigation could be conducted as required by your firm’s SOP CDP-SOP-702.
b. The Preventive Action section of CAPA #110717-1 concluded, “Instruct the team to have (b)(4)”; however, the “Process Manufacturing Management Standard”, CDP-WI-05 used for the manufacture of Chemview-10 product has not been updated to include this instruction; changes to this procedure have not been implement to correct this quality problem.
c. CAPA #110717-1 lacks the identification of the lot involved in this complaint and the resolution of the impacted lot; all actions to correct the problem have not been identified.
2) Failure to establish and maintain procedures for validating the device design, as required in 21 CFR 820.30(g).
a. Your firm failed to establish a stability validation protocol/ procedure for both Chemview-10 and Chemview-11. You had stated that your firm did not establish protocols for the stability study validation.
b. Your firm also failed to validate the long term stability claim of the 24 month lifespan specification for the Chemview-11 device. Your firm was unable to provide additional documents and records upon request by the investigator.
c. In addition, your firm’s accelerated stability test report did not fully describe the test method (e.g., (b)(4)). Your firm was unable to provide additional documents and records upon request by the investigator.
d. Your firm failed to maintain raw data of the accelerated stability test for Chemview-11, Lot #(b)(4) to support the results documented (i.e., product’s expiration date).You had stated that your firm did not maintain raw data.
e. Your firm’s accelerated stability test report for Chemview-11, Lot #(b)(4) lacked the identification of the preparer and the date of the report. Your firm was unable to provide additional documents and records upon request by the investigator.
f. Your firm’s accelerated stability test report did not identify the equipment used in the stability study. Your firm was unable to provide additional documents and records upon request by the investigator.
3) Failure to establish and maintain procedures to control product that does not conform to specified requirements, as required by 21 CFR 820.90(a). Products that do not conform to specifications are not adequately controlled.
For example: Nonconforming report CD-110915-1 documented that (b)(4) of S.G. 1, lot #(b)(4), was detected with (b)(4), for which a laboratory investigation was requested. Laboratory personnel performed the investigation by running (b)(4) verification tests; however, no investigation report was generated to verify whether the correct formulation was employed during the manufacture of S.G. 1, lot #(b)(4), to confirm the validity of the nonconformity, and to draw a conclusion of what might have caused the (b)(4). The investigation was not documented for this nonconformance. Similarly, a nonconforming event investigation of (b)(4) lot (b)(4) lacked an investigation identifier (i.e., non-conforming product registration number), as required by “Non-Conforming Product Management”, CDP-SOP-804 and CDP-F-804-01 (form used to document nonconformance).
4) Failure to establish and maintain procedures that define the responsibility for review and the authority for the disposition of nonconforming product, as required by 21 CFR 820.90(b)(1).
For example, procedures that define the responsibility for review and the authority for the disposition of nonconforming product have not been adequately established. Specifically, your firm’s nonconforming report CD10-SJ-08, dated 6/3/2010, identified that (b)(4) labels of Self-Stick 9 Plus were mislabeled. Your firm said these labels were destroyed; however, your firm failed to properly document the method of destruction, the place and date of the destruction, the person conducting the destruction and the destroyed quantity. You have stated that the labels were destroyed without proper documentation.
5) Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a).
For example, procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been adequately established. Specifically,
a. CDP-SOP-702, Rev. 1 “Customer Complaint Process” did not specify a relevant time frame for the complaint disposition. Complaint #CDP-100501 pertaining to the mislabel of Self-Stik 9 Plus has not been closed since the issue of the final report CD10-SJ-08 on 06/3/2010.
b. An oral complaint was received on 07/17/2011 stating that an incorrect quantity of Nitrate 10T (Chemview-10) was shipped to (b)(4). You have stated that you received the above-mentioned complaint and that you did not document it, as required by your firm’s procedure, CDP-SOP-702, Rev. 1 “Customer Complaint Process”. When asked whether your firm got any information on the subject lots identification, and how the complaint situation was settled, you did not offer an answer about the lot identification but said that (b)(4) had resolved the issue.
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. 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, 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 (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. 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 Operations Branch, White Oak Building 66, Rm 2609, 10903 New Hampshire Ave., Silver Spring, MD 20993. Refer to CMS case #406088 when replying. If you have any questions about the contents of this letter, please contact: James L. Woods, at 301-796-6225 or fax 301-847-8513.
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.
Office of In Vitro Diagnostics and
Center for Devices and