Inspections, Compliance, Enforcement, and Criminal Investigations
CASMED International, Ltd. 11/15/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
10903 New Hampshire Avenue
NOV 15, 2012
VIA UNITED PARCEL SERVICE
Dr. Deborah M. Castle
CASMED International, Ltd.
Unit C, Blenheim House, 1 Blenheim Road
Epsom,Surrey KT19 9AP United Kingdom
Dear Dr. Castle:
During an inspection of your firm located in Surrey, United Kingdom, on August 15, 2012, through August 16, 2012, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures Oocyte Aspiration Needles, Procedure Needles, Camera Covers, Needle Guides, Trocars and Cannulas, and Tubing Sets. 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 August 23, 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 validate the results of a process with a high degree of assurance and approve it according to established procedure, where the results of a process cannot be fully verified by subsequent inspection and test, as required by 21 CFR 820.75(a).
For example, your firm's Assisted Reproduction Needles are (b)(4) sterilized by a contract manufacturer using the (b)(4), Serial # (b)(4). However, the (b)(4) sterilization process has not been validated.
We reviewed your firm’s response dated August 23, 2012. The adequacy of your firms response cannot be evaluated at this time. Your firm has indicated that it has located the sterilizer commission date of (b)(4) in its records. However, your firm stated that it was unable to obtain a copy of the report because the contract company is no longer in existence. Your firm has also indicated that it would take about (b)(4) weeks to have the Sterilizer revalidated.
2. 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 does not have design control procedures in place to ensure that specified design requirements are met and your firm has not subjected the Oocyte Aspiration Needles through a design control process.
We reviewed your firm’s response dated August 23, 2012. The adequacy of your firm’s response cannot be determined at this time because your firm indicated that it will submit a design control procedure to the agency in (b)(4) weeks.
3. Failure to establish and maintain procedures, for controlling labeling activities, as required by 21 CFR 820.120.
a) Your firm's Labeling of Stock Work Instruction, Instruction Sheet No. 5, Revision 3, does not include a requirement for labeling inspection. The procedure fails to require a designated individual to examine the labeling for accuracy prior to release for storage or use.
b) Your firm has yet to establish a labeling procedure for the Assisted Reproduction Needles
Your firm’s response to this observation appears to be adequate. Your firm has submitted 3 revised Work Instruction Work Sheets: Numbers 5-Device History Recording-Rev-4, 9-Stores Control Rev-5, and 11-Goods Received Rev-3. The work instruction sheets include requirements for labeling inspections, the date and signature of individuals performing the examination, and instructions to document in the Device History Record.
4. 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 21 CFR 820, as required by 21 CFR 820.184.
For example, your firm has not established a DHR procedure. Also, during the inspection, a review of (b)(4) DHRs from 2009 through 2012 (pertaining to the assisted reproduction needles) did not include or reference the location of the primary identification label and labeling used for each production unit.
We reviewed your firm’s response dated August 23, 2012. It appears to be adequate. Your firm has submitted 3 revised Work Instruction Work Sheets: Numbers 5-Device History Recording-Rev-4, 9-Stores Control Rev-5, and 11-Goods Received Rev-3. The work sheets include requirements for labeling inspections, the date and signature of individuals performing the examination, and instructions to document in the DHR.
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 #366459 when replying. If you have any questions about the contents of this letter, please contact: Debra Demeritt at Telephone: 301-796-5770 or Fax 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 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
Friedel M. Zander
Zander Scientific, Inc.
7558th Court, Suite #4
Vero Beach, Florida 32962