Batrik Medical Mfg., Inc. 9/23/13
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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
September 23, 2013
VIA UNITED PARCEL SERVICE
Batrik Medical Mfg., Inc.
850 Halpern Avenue
Dear Mr. Goldberg:
During an inspection of your firm located in Dorval, Canada, on June 25, 2013, through June 27, 2013, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures vascular silicon ties. 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. These violations include, but are not limited to, the following:
1. Failure to ensure, where 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 has no documentation to demonstrate that the (b)(4) process for (b)(4) used to (b)(4) product, such as vascular silicone ties, has been validated.
2. Failure to establish and maintain procedures to control product that does not conform to specified requirements, as required by 21 CFR 820.90(a). For example, Non-conforming Product Procedure/PS-02, revision 8, does not address how non-conforming product will be identified and segregated. The device history record for the manufacture of lot (b)(4) of vascular silicon ties shows that (b)(4) products were not packaged due to defects. However, the non-conforming product was not segregated or labeled for disposition.
3. Failure to establish and maintain procedures to ensure that device history records (DHRs) for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the device master record and the requirements of this part, as required by 21 CFR 820.184. For example, the DHR of Vascular Silicon Ties/(b)(4) (Lot (b)(4)) does not document that all product released had been sterilized. The sterilization record shows that (b)(4) pieces of Lot (b)(4) were sterilized on (b)(4). However, the packaging records for the lot show that (b)(4) pieces were packaged ((b)(4) pieces were packaged on (b)(4), (b)(4) pieces on (b)(4), and (b)(4) pieces on (b)(4)). There is no record of the pouching operation and no documentation of the quantity of product that was pouched.
A follow-up inspection will be required to assure that corrections and/or corrective actions are adequate.
The 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 #410595 when replying. If you have any questions about the contents of this letter, please contact: LaShanda Long at 301-796-5465 or fax number 301-847-8137.
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.
Steven D. Silverman
Office of Compliance
Center for Devices and