- Lac-Mac Limited
- 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|
White Oak Building 66
Silver Spring, MD 20993
APR 1, 2015
VIA UNITED PARCEL SERVICE
Lac Mac, Ltd.
847 Highbury Avenue North
London, ON N5Y 5B8
Dear Mr. Garvey:
During an inspection of your firm, located in 847 Highbury Avenue North, Building 2, London, Ontario, on November 3, 2014, through November 6, 2014, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures surgical gowns, sterile wraps, and surgical drapes. 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 November 25, 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 to control the design of the device in order to ensure that specified design requirements are met, as required by 21 CFR 820.30(a). For example: your firm’s design control procedures do not ensure that design input and outputs, design verification and validation, design review, design changes, and design transfer activities are conducted and documented. Your firm’s design history files (DHFs) do not contain or provide reference to this information.
We reviewed your firm’s response and conclude that it is not adequate. Your firm provided revised design control procedures and personnel training records for these procedures. However, your firm did not conduct a retrospective review of its DHFs to ensure that design control activities are adequately conducted and documented.
2. Failure to establish and maintain adequate procedures for implementing corrective and preventive action (CAPA), as required by 21 CFR 820.100(a). For example:
a. Your firm’s CAPA procedure does not include the requirements for:
i. Analyzing quality data to identify the existing and potential causes of nonconforming product or other quality problems.
ii. Investigating the cause of nonconformities relating to product, processes, and the quality system.
iii. Identifying the actions needed to correct and prevent recurrence of nonconforming product or other quality problems.
iv. Verifying and validating corrective and preventive actions.
v. Implementing and recording changes necessary to correct and prevent identified quality problems.
vi. Disseminating information related to quality problems and nonconforming product to those directly responsible for assuring quality.
vii. Submitting relevant information on identified quality problems and CAPA actions for management review.
viii. Documenting all CAPA activities.
b. Your firm’s CAPA record numbers 137, 138, 143, and 144 did not document investigation results, validation of the corrective actions, and implementation dates of the actions taken.
c. Your firm’s CAPA record number 138, related to multiple complaints involving incorrect placement of bar codes, did not contain documentation of corrective actions:
i. Including verification or validation of the corrective and preventive actions taken to ensure that the actions were effective.
ii. Documentation of corrective actions.
We reviewed your firm’s response and conclude that it is not adequate. Your firm revised its CAPA procedure to addresses the procedural deficiencies and provided personnel training records for the revised procedure. However, your firm did not conduct a retrospective review of CAPAs to determine if the CAPA activities were adequately verified or validated.
3. Failure to ensure that where the results of a process cannot be fully verified by subsequent inspection and test, the process is validated with a high degree of assurance and approved according to established procedures, as required by 21 CFR 820.75(a). For example:
a. Your firm did not retain documentation of qualification and validation activities associated with (b)(4).
b. Your firm did not assess the need for revalidation of the (b)(4) process using a (b)(4), installed in the production line.
We reviewed your firm’s response and conclude that it is not adequate. Your firm provided revised process validation procedures and personnel training records for the revised procedures. However, your firm did not conduct a retrospective review of other manufacturing processes to determine if existing processes and equipment are adequately validated.
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, your firm’s nonconformance procedures do no describe the requirements for the review and documentation of the disposition process, including justification for use and the signature of the individual authorizing the use of the nonconforming products.
We reviewed your firm’s response and conclude that it is not adequate. Your firm provided a revised nonconformance procedure and personnel training records for this procedure. However, your firm did not conduct a retrospective review of nonconformance reports to determine if they were appropriately disposed.
5. Failure to establish and maintain procedures to ensure that Device History Records (DHR’s) for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the Device Master Records, as required by 21 CFR 820.184. For example:
a. Your firm does not have procedures for maintaining DHR’s.
b. Your firm’s batch records for surgical drapes, surgical gowns, and wraps for orders (b)(4) did not include in process and finished product acceptance records.
We reviewed your firm’s response and conclude that it is not adequate. Your firm provided a DHR procedure and personnel training records for this procedure. However, your firm did not conduct a retrospective review of its DHRs for similar deficiencies.
6. Failure to ensure that all inspection, measuring, and test equipment, including mechanical, automated, or electronic inspection and test equipment, is suitable for its intended purposes and is capable of producing valid results, and to adequately establish and maintain procedures to ensure that equipment is routinely calibrated, inspected, checked, and maintained, as required by 21 CFR 820.72(a). For example:
a. Your firm’s calibration procedure does not include the requirements to ensure that:
i. All inspection, measuring, and test equipment is suitable for its intended purpose and capable of producing valid results.
ii. Handling, preservation, and storage of equipment are performed to maintain the accuracy and fitness of equipment.
iii. Calibrations, inspections, checks, and maintenance activities are documented.
iv. Calibration standards are traceable to national or international standards, or if necessary, an independent, reproducible standard.
v. Equipment identification, calibration dates, the individual performing each calibration, and the next calibration date are documented.
vi. Calibration records are displayed on or near the equipment or readily available to personnel using the equipment and individuals calibrating the equipment.
vii. Specific directions and limits for accuracy and precision are included.
viii. Provisions for remedial action when accuracy and precision limits are not met, and the documentation of these remedial actions.
b. Your firm does not have calibration records for the (b)(4), the (b)(4), and the (b)(4).
We reviewed your firm’s response and conclude that it is not adequate. Your firm revised its calibration procedure, work instructions, and provided a documentation chart for equipment requiring calibration. However, your firm did not provide personnel training records for these revised documents. In addition, your firm did not evaluate whether the lack of an adequate calibration procedure could have resulted in the release of nonconforming products.
Given the serious nature of the violations of the Act, the devices manufactured by your firm, including the surgical gowns, sterile wraps, and surgical drapes, are subject to refusal of admission under section 801(a) of the Act, 21 U.S.C. § 381(a), in that they appear to be adulterated. As a result, FDA is taking steps to refuse entry of these devices into the United States, known as “detention without physical examination,” until these violations are corrected. In order to remove the devices from detention, your firm should provide a written response to this Warning Letter as described below and correct the violations described in this letter. 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.
Also, 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 actions (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 2622, 10903 New Hampshire Ave., Silver Spring, MD 20993.Refer to CMS case #446956 when replying. If you have any questions about the contents of this letter, please contact: Daniel Walter, Chief, Foreign Enforcement Branch, at +1 (301) 796-5587, or fax +1 (301) 847-8139.
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.
Jan B. Welch, MHS, MT (ASCP) SBB
Office of Compliance
Center for Devices and
Emergo Group Inc.
816 Congress Avenue
Austin, Texas 78701
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