| Public Health Service Food and Drug Administration |
| 10903 New Hampshire Avenue Silver Spring, MD 20993 |
Department of Health and Human Services
WARNING LETTER
OCT 13, 2011
VIA UNITED PARCEL SERVICE
Mr. R. L. Bernberg
Managing Director
Rocket Medical Plc
Sedling Road
Factories 2-4 Wear Industrial Estate
Washington
Tyne & Wear NE38 9BZ
United Kingdom
Dear Mr. Bernberg:
During an inspection of your firm located in Washington, 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 IVF devices (catheters, fetal bladder stents, uterine sound devices, etc). 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.
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 (CGMP) requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820.
We received a response from (b)(6) QA Manager, incorrectly dated October 27, 2011, that was received July 29, 2011, 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 establish and maintain adequate procedures to control the design of the device in order to ensure that specified requirements are met, as required by 21 CFR 820.30(a).
For example, design procedure SOP 2200/Manufacture and sale of all Product Codes did not include requirements or the location of records for design planning, design inputs, design outputs, design verification, design validation, design transfer, and risk assessment.
Your firm’s response received July 29, 2011, is not adequate. Your response only states that your firm will review and update SOP 2200. Information on the systemic corrective action was not provided. Additionally, this observation was observed during the previous inspection conducted in 2006, and an adequate corrective action has still not been implemented.
2. Failure to establish and maintain adequate procedures for implementing corrective and preventive actions, as required by 21 CFR 820.100(a).
For example:
a. Your firm’s Standard Operating Procedure/Corrective & Preventative Action Report (SOP 3104) does not include the following requirements:
i. Analysis of potential causes of nonconforming products or quality problems does not take into consideration a review of work processes, service records, and returned products
ii. Investigating the cause of nonconformities
iii. Verification or validation of the corrective or preventive actions
iv. Ensuring that information related to quality problems on nonconforming product is disseminated to those directly responsible for assuring quality of products or prevention of problems
b. CAPA/(b)(4) was opened in September, 2010, for (b)(4) Assay testing failures for IVF product. The CAPA does not include a documented investigation but identifies some process steps as potential corrective actions. These corrective actions were not implemented. The CAPA had a target completion date of December, 2010. At the time of FDA inspection, the investigation by the testing laboratory (b)(4) was not complete.
c. CAPA/(b)(4) was opened due to a complaint of (b)(4) of Bulb Tip Catheter/57635-00-18. The corrective action was to (b)(4) There is no documented investigation of the (b)(4) problem. There is no documentation that the corrective action was verified.
Your firm’s response received July 29, 2011, is not adequate. Your firm has indicated that it will review and update SOP 3104. The systemic corrective action was not provided nor was any corrective action mentioned for the missing information in the corrective actions CAPA/(b)(4) and CAPA/(b)(4).
3. Failure to adequately establish and maintain adequate procedures to 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, the (b)(4)/SOP 4102 does not describe the (b)(4) acceptance criteria, the alert and action levels, or where this information can be obtained. Also, the SOP 4100 for the (b)(4) does not describe the acceptance criteria or the alert and action levels used to determine when a corrective or preventive action needs to be opened. Your firm has experienced (b)(4) over the last year without prompt action.
Your firm’s response received July 29, 2011, is not adequate. Your firm has indicated that it will review and update SOPs 4100 and 4102. The response did not discuss the systemic corrective action.
4. Failure to establish and maintain adequate 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 DMR and the DHR requirements, as required by 21 CFR 820.184.
For example, the Device History Record (Work Order Document) does not provide documentation to demonstrate that products were manufactured in accordance with the Standard Procedure. In particular, the device history record (Work Order Document) for Lot 004365761 of Embryon Bulb Tip ET Catheter/R57635-00-18 does not include documentation that (b)(4) was 100% inspected as required per the Procedure for R57635-00-18.
Your firm’s response received July 29, 2011, is not adequate. Your firm has indicated that its operator will confirm the completion of each manufacturing stage of the device history record; however, the systemic corrective action was not provided or discussed.
5. Failure to establish and maintain adequate procedures to control products that do not conform to specified requirements, as required by 21 CFR 820.90(a).
For example, the Control of Non-conforming Product procedure, SOP 3202, requires a scrap record sheet to be completed. The (b)(4) testing of Embryon Bulb Tip ET Embryo Transfer Catheters/R57635-00-18 Lot 436023 revealed that this product was tested for (b)(4) and it was found that 51 of the (b)(4) pieces were found to have (b)(4) The 51 pieces were reportedly scrapped, but there is no documentation of the disposition of these pieces.
Your firm’s response received July 29, 2011, is not adequate. Your firm has indicated that it is conducting investigations on how to utilize the QA Infinity software to control and record products that do not conform to specification. The response did not address the systemic corrective action.
A follow up inspection will be required to assure that corrections and/or corrective actions are adequate.
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 #217075 when replying. If you have any questions about the contents of this letter, please contact: Paul Tilton, Branch Chief, OBGYN, Gastroenterology and Urology Devices Branch of the Division of Enforcement A, Office of Compliance, CDRH at telephone 301-796-5484 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 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.
Sincerely yours,
/S/
Steven D. Silverman
Director
Office of Compliance
Center for Devices and
Radiological Health
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