- Precision Needle Manufacturing, Inc.
- Issuing Office:
- Center for Devices and Radiological Health
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||10903 New Hampshire Avenue|
Silver Spring, MD 20993
MAY 25, 2014
VIA UNITED PARCEL SERVICE
Chief Executive Officer
Precision Needle Manufacturing Company
Republic of Korea
Dear Mr. Kang:
During an inspection of your firm located in Gyunggii-Do, Republic of Korea on January 6, 2014, through January 9, 2014, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures guidewire introducers, saline flushing solution,and glass syringes. 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 your firm, dated January 21, 2014, concerning our investigator's observations noted on the Form FDA 483 (FDA 483), List of lnspectional 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 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, nonconformance reports (b)(4), (b)(4), and (b)(4) were opened for dents found in Crawford needles, outer diameter failures with tip protectors for needles, and inner diameter failures with star guard protective tubing parts. The reports did not adequately record the disposition of the nonconforming product. Additionally, nonconformance report (b)(4) did not record the justification for use of nonconforming product.
The adequacy of the response dated January 31, 2014, cannot be determined at this time because your firm has not yet conducted its verification activities, which include a review of nonconformance records by quality assurance on a monthly basis for a minimum of 6 months. Your firm estimated that this will be completed by August 2014.
2. Failure to establish and maintain procedures to ensure that mix-ups, damage, deterioration, contamination, or other adverse effects to product do not occur during handling, as required by 21 CFR 820.140.
For example, your firm's procedure SOP-(b)(4) requires products to be put into a (b)(4) bag and sealed to prevent contamination. However, during the inspection, it was noted that bins containing needle protectors were exposed.
The adequacy of the response dated January 31, 2014, cannot be determined at this time because your firm has not yet conducted verification activities, which include a documented weekly spot check of manufacturing areas for two months during operation to demonstrate effective use of the procedures, to ensure that the material is covered when it isnot in use, and to ensure that bins are kept and stored above floor level. Your firm estimated that this will be completed by April 2014.
3. Failure to ensure, when the results of a process cannot be fully verified by subsequent inspection and test, that the process shall be validated with a high degree of assurance and approved according to established procedures, as required by 21 CFR 820.75(a).
For example, your firm's protocol (b)(4) Performance Qualification Protocol for Guide Wire Introducer Needle Process (b)(4), required that all report data sheets must be signed and dated by the individuals responsible for recording and verifying the data during test. execution. The protocol also requires that the equipment used, and its calibration status, be recorded on the test forms. Your firm failed to document the execution of its protocol. The dates of testing, the individual conducting the visual inspection testing, the individual conducting the tensile testing, the equipment used, and the calibration status were not recorded.
The response dated January 31, 2014, is not adequate because the verification of the corrective action is not yet completed and, although training was conducted for the personnel involved in the new validation with (b)(4), your firm did not evaluate whether general training on SOP (b)(4) Process Validation was needed.
4. Failure to document all activities required for corrective and preventive actions, and their results, as required by 21 CFR 820.100(b).
For example, CAPA files 028-000, 029-000, and 030-000 do not include documentation of the investigations that were conducted by your firm to identify the root cause of the nonconforming products.
The adequacy of the response dated January 31, 2014, cannot be determined at this time because the verification of the corrective action is not yet completed. Also, your firm states that CAPAs were reviewed. However, your firm did not submit documentation to demonstrate that a retrospective review was conducted of executed CAPAs from the year prior to the inspection to ensure that similar deficiencies are addressed and determine if further corrective actions are necessary.
5. Failure to include required information in records of complaint investigations, as required by 21 CFR 820.198(e).
For example, Complaint Records 050-000, 055-000, 070-000, 072-000 and 075-000 did not include the dates and results of the investigations, all corrective actions taken, and any replies to the complainant as required by your firm's complaint handling procedure SOP-(b)(4).
The response dated January 31, 2014, is not adequate because, although the complaint records now include more attachments, it is unclear whether these attachments document the dates and results of the investigation, all corrective actions taken, and the replies to the complainants. Additionally, your firm has not yet conducted its verification activities, which include a monthly review of the status and reports on customer rejections to demonstrate a compliant process per the revised procedure, with all required documentation, by quality assurance for a minimum of 6 months. Your firm estimated that this will be completed by August 2014. The adequacy of your firm's verification activities cannot be determined without review.
6. Failure to define the type and extent of control to be exercised over the product, services, suppliers, contractors, and consultants, based on evaluation results, as required by 21 CFR 820.50(a)(2).
For example, your firm's supplier audit schedule listed (b)(4), for an audit in 2012. However, your firm did not conduct the supplier audit as specified.
The adequacy of the response dated January 31, 2014, cannot be determinedat this time because your firm has not yet conducted verification activities, which include review of supplier activity for 6 months by quality assurance to demonstrate the effective use of the vendor monitoring procedures and schedules. Your firm estimated that this will be completed by August 2014.
A follow up inspection may be required to assure that corrections and/or correctiveactions are adequate. 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 Illdevices 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 # 428715 when replying. If you have any questions about the contents of this letter, please contact: Daniel Walter, Chief, Foreign Enforcement Branch, Division of International Compliance Operations, Office of Compliance, Center for Devices and Radiological Health, Tel: 301-796-5587 or Fax: 301-847-8138.
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 lnspectional 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.
Steven D. Silverman
Office of Compliance
Center for Devices and