Inspections, Compliance, Enforcement, and Criminal Investigations
Intersurgical, Ltd. 12/27/11
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
10903 New Hampshire Avenue
DEC 27, 2011
VIA UNITED PARCEL SERVICE
Mr. Howard Bellm
Molly Millar’s Lane
Berkshire UK RG 41 2RZ
Dear Mr. Bellm:
During an inspection of your firm located in Wokingham, United Kingdom, on July 11, 2011, through July 14, 2011, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures single use, non-sterile products used for the delivery of gas, aerosols, and anesthetics to the lungs as well as a consumable carbon dioxide absorbent used in anesthetic re-breathing and respiratory therapy equipment. 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 are intended to affect the structure or function of the body.
Our inspection revealed that the these products are misbranded under Section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), in that your firm failed or refused to furnish material or information respecting the device that is required by or under Section 519 of the Act, 21 U.S.C. § 360i, Title 21, Code of Federal Regulations (CFR), Part 803 - Medical Device Reporting. These violations include, but are not limited to, the following :
Failure to develop, maintain, and implement written Medical Device Reporting (MDR) procedures, as required by 21 CFR 803.17.
For example, when the MDR procedure was requested, your firm’s representative stated that your firm does not report MDRs to the FDA since that is accomplished through Intersurgical, Inc., the U.S. firm for which your firm contract manufactures. Your firm is considered to be a manufacturer by definition and is therefore required to have an MDR procedure.
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, as well as 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 (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. Your firm’s response should be comprehensive and address all violations included in this Warning Letter. Please provide a translation of documentation not in English to facilitate our review.
In addition, FDA has noted nonconformances with regards to section 501(h) of the Act (21 U.S.C. § 351(h)), which are deficiencies within your firm’s quality system pertaining to current good manufacturing practice requirements specified in the Quality System regulation found at 21 CFR Part 820. These nonconformances include, but are not limited to, the following:
1. Failure to adequately establish and maintain procedures to control labeling and packaging operations to prevent labeling mix-ups, as required by 21 CFR 820.120(d).
For example, a review of 27 Device History Records (DHRs) for the (b)(4) used in breathing systems found that 14 of the 27 DHRs lacked the correct primary identification label and labeling used for each production unit. Specifically:
i) The DHR for Lot No. 1101832 identifies (b)(4) canister units released for distribution. The (b)(4) in IQR119.DOC for this same lot indicates that there were (b)(4) case labels issued for the lot, with one label being retained in the DHR. The remaining (b)(4) labels (10 canisters per box) account for a total of (b)(4) canister units; however, the “QTY RELEASED” for the lot identifies that (b)(4) canister units in the lot were released.
ii) Lot No. 1102176 called for a total of (b)(4) canister units. The (b)(4) for this DHR lacked documentation that any labels were issued and checked for accuracy for the lot.
2. The DHR requires (b)(4) testing to be performed on in-process material with product specifications specific to each product listed in the DHR. In the event of test results outside of product specifications, the DHR also requires that additional tests be performed and failures documented on the IQR39 (DHR). The review of 27 DHRs for the (b)(4) used in breathing systems found that in-process (b)(4) testing was not performed in accordance with work instructions identified in IWI 1086, (b)(4) Specifically, the DHR for Lot No. 1101832 noted that the (b)(4) test performed on 6/10/2010 failed in-process testing. There was no immediate retesting of the lot as required by the work instructions. Further testing also failed, yet there was no indication that a Supervisor or Engineer was notified of the in-process failures as required by the work instructions. In addition, there was no documentation that an investigation or evaluation was performed to evaluate and determine the suitability of the product. Of the 27 DHRs reviewed, 9 DHRs contained a failure to retest or failure to document a review of the DHR by a responsible management representative to assure that the lot was suitable for release.
3. Failure to establish and maintain procedures to control all documents that are required by the Quality System Regulation, as required by 21 CFR 820.40. For example, the investigator reviewed the (b)(4) and noted changes to manufacturing settings for the (b)(4) used in the (b)(4). When discussed with your firm’s representative, it was noted that the changes were not set based on validated times and approved by the appropriate individuals as defined in Section 4.1 of the firm’s IQP 501, (b)(4)
Your firm’s response to this letter 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 the Unique Identification Number (CMS case # 251294 when replying. If you have any questions about the contents of this letter, please contact: Charles Cathlin at 301-796 5548 or via fax at 301-847-8128.
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 Radiological Health