Central Surgical Co. Ltd. 12/27/12
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||10903 New Hampshire Avenue|
Silver Spring, MD 20993
December 27, 2012
VIA UNITED PARCEL SERVICE
John R. Corroyer
Central Surgical Co. Ltd.
82a-84a Citizen Road
London, United Kingdom N7 7NN
Dear Mr. Corroyer:
During an inspection of your firm located in London, United Kingdom, on August 13-14, 2012, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures oocyte aspiration needles. 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 on behalf of your firm dated September 11, 2012, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations that 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 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 procedure, as required by 21 CFR 820.75(a). For example, your firm currently uses (b)(4) process has yet to be validated.
We reviewed your firm’s response and conclude that it is not adequate. The response states that the sterilization validation was conducted at the initial installation of the autoclave; however, the sterilization documents could not be located. A re-validation was to occur on September 10-11, 2012; however, your firm has not provided any technical information to demonstrate that the re-validation has been conducted.
2. Failure to establish and maintain procedures to include requirements for identifying the actions needed to correct and prevent recurrence of nonconforming product and other quality problems, as required by 21 CFR 820.100(a)(3). For example, your firm failed to identify the actions needed to correct and prevent recurrence when the (b)(4) limits were exceeded during (b)(4) bio-burden testing.
We reviewed your firm’s response and conclude that it is not adequate. Your firm revised the Technical Agreement between (b)(4) and (b)(4), by stating that (b)(4) will send a copy of the bio-burden results that must be retained at (b)(4) along with any corrective action that must be taken. The response states that both (b)(4) and (b)(4) personnel have been retrained on the revised agreement; however, no documentation was submitted as evidence of this. In addition, your firm did not indicate that it retrospectively reviewed previous bio-burden results to ensure that bioburden limits had not been exceeded.
3. Failure to develop, conduct, control, and monitor production processes to ensure that a device conforms to its specifications, as required by 21 CFR 820.70(a). For example, (b)(4) of (b)(4) sterilization batches from 2012 were sterilized using (b)(4) units, whereas the firm’s Sterilization Work Instruction, Document #WI-CS10, states, “Do not exceed the load capacity of the sterilizing cage of (b)(4) units for each sterilizing batch run.”
We reviewed your firm’s response and conclude that it is not adequate. The response states that your firm has re-trained staff on the Sterilization Work Instruction, pointing out that the load capacity cannot exceed (b)(4) units. However, no documentation was submitted to demonstrate that re-training has taken place and there is no evidence that your firm reviewed previous batches to ensure that the load capacity was not exceeded.
4. Failure to establish and maintain procedures to adequately control environmental conditions that could reasonably be expected to have an adverse effect on product quality, as required by 21 CFR 820.70(c). For example, your firm’s Cleanroom Air Monitoring Work Instruction, Document #WI-CS20, requires a (b)(4) testing for monitoring the (b)(4) and (b)(4); however, the work instruction fails to include the monitoring of personnel.
We reviewed your firm’s response and conclude that it is not adequate. The response states that the Cleanroom Air Monitoring Work Instruction will be re-written to include the monitoring of cleanroom personnel; however, the revised work instruction was not submitted for review.
Given the serious nature of the violations of the Act, oocyte aspiration needlesmanufactured by your firm 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 may take steps to refuse these products, 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 if your firm’s response appears to be adequate, and we may 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. 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 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. 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 #383378 when replying. If you have any questions about the contents of this letter, please contact Mrs. Debra E. Demeritt at 301-796-7550 or 301-847-8137(fax).
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