| Public Health Service Food and Drug Administration |
| New England District One Montvale Avenue Stoneham, Massachusetts 02180 (781) 596-7700 FAX: (781) 596-7896 |
Department of Health and Human ServicesWARNING LETTER
NWE-01-11W
VIA United Parcel Services
October 1, 2010
Ms. Ellen Berman
President
Sepal Reproductive Devices, Inc.
100 Beach Street, Ground Floor
Boston, Massachusetts 02111
Dear Ms. Berman:
During an inspection of your firm located in Boston, MA, on May 6, 2010, through May 26, 2010, investigators from the United States Food and Drug Administration (FDA) determined that your firm manufactures "Total Conception". 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 (OS) regulation found at Title 21, Code of Federal Regulations (C.F.R.), Part 820. These violations include, but are not limited to, the following:
1. Failure to establish and maintain procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a).
For example, when the investigator asked if you had CAPA procedure and a subsystem in place, you indicated that you did not. Your firm does not have a system in place to perform corrective and preventative steps when events of nonconformance occur. The CAPA procedure you provided to the investigator during the inspection was inadequate.
2. Failure to establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements, as required by 21 CFR 820.50.
For example, Ms. Stephanie Berman, your Product Manager, General Manager and Vice President of Marketing, indicated that any sterility assurance comes from the manufacturers and that you keep Certificates of Analysis on products from (b)(4) your component manufacturer. When asked by the investigator for documentation of sterility or certificate of analysis from the manufacturers of your components, you indicated that you did not have any. Your firm does not have documentation of evidence of the sterility of the Total Conception's components (b)(4), and (b)(4) that are labeled as sterile and that you indicated were to be sterilized by your component manufacturers.
3. Failure to establish and maintain procedures for the identification, documentation, validation or where appropriate verification, review, and approval of design changes before their implementation, as required by 21 CFR 820.30(i).
For example, you did not document changes that occurred to the Total Conception within the past year, including the deletion of a component (b)(4), from the Total Conception.
4. Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a).
For example, when asked by the investigator if you had any complaints or a complaint handling procedure, you indicated you had never had any complaints and that if you did, you would just pass it on to manufacturing. Your employee provided a complaint procedure when the investigator returned to your firm on May 19, 2010; the complaint handling procedure and record provided to the investigator were inadequate and there was no date on the procedure provided.
5. Failure to establish and maintain procedures for the control of storage areas and stock rooms for product to prevent mixups, damage, deterioration, contamination, or other adverse effects pending use or distribution and to ensure that no obsolete, rejected, or deteriorated product is used or distributed, as required by 21 CFR 820.150(a).
For example, when the investigator visited your firm, expired products were on storage shelves directly adjacent to products ready for shipment to customers without adequate identification to distinguish between expired and non-expired products. A box of Reimplantation catheters with Introducers for embryo transfer during In Vitro Fertilization, which had an expiration date of "2008/12," was stored on shelves containing products which were ready to be distributed. Also, boxes of expired Tuberculin were stored next to Reimplantation catheters with Introducers which were ready to be distributed.
6. Failure to maintain adequate device master records (DMR's), as required by 21 CFR 820.181.
For example:
A. There are no lists of component, packaging or labeling, or quality assurance specifications for the 18 components that are a part of the Total Conception, some of which are labeled as sterile. When the investigator asked for the device master record, you indicated that the list of what went into the kits was on the brochures.
B. There are no component specifications or packaging or labeling specifications for the Sepal Reproductive Devices OVUSponse Ovulation Predictor. When the investigator asked for the device master record, you indicated that the list of what went into the kits was on the brochures. The OVUSponse Ovulation Predictor can be sold individually or as a part of The Total Conception.
C. There are no component specifications or packaging or labeling specifications for the Sepal Reproductive Devices One-Step Pregnancy Test. When the investigator asked for the device master record, you indicated that the list of what went into the kits was on the brochures. The One-Step Pregnancy Tests are included in the Total Conception.
D. The allowable length of time to expiration for the pregnancy tests and OVUSponse Ovulation Predictor kits are unknown. The General manager and Vice President of Marketing said that expiration dates are always at least a year, sometimes more.
7. Failure to establish and maintain procedures to ensure that device history records (DHR's), for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the DMR and the requirements of this part, as required by 21 CFR 820.184.
For example:
A. Your firm has not maintained DHRs for any of the. "Total Conception" conception assistance kits or any of the (b)(4) "OVUSponse Ovulation Predictor" kits that have been distributed as of May 6, 2010. When requested by the investigator, you indicated that you did not have any DHRs.
B. Lot numbers and expiration dates of some components of the Total Conception are included on the customer invoice; however the recorded lot numbers and expiration dates do not indicate which components they go with. Specifically, invoice #15560 does not list any components by part number or name, but does include 4 lot numbers with expiration dates and one lot number without an expiration date. The (b)(4) in house was from lot #3040, but had an expiration date of December 2012 rather than February 2012 as recorded on invoice #15560. Device identification(s) and control numbers used were not included or referenced in a DHR.
C. Copies of labels for units shipped to customers are not maintained and no labeling specifications are referenced in the DHR.
8. Failure to establish procedures for quality audits and conduct such audits to assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system, as required by 21 CFR 820.22.
For example, you did not have documentation to indicate quality audits were performed. Also, you did not have procedures in place for conducting quality audits.
Our inspection also revealed that your devices 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, and 21 C.F.R. Part 803 - Medical Device Reporting (MDR) regulation. Significant deviations include, but are not limited to, the following:
Failure to develop, maintain, and implement written MDR procedures, as required by 21 CFR 803.17.
For example, during the May 6, 2010, through May 26, 2010, inspection of your firm, the FDA investigators noted that you did not have MDR procedure in place. When asked by the investigator if you were familiar with MDRs, you indicated you were not familiar with what they were.
Our inspection also revealed that your devices are adulterated under section 501 (f)(1)(B) of the Act, 21 U.S.C. 351 (f)(1)(B), because you do not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C.360j(g). The device is also misbranded under section 502(o) the Act, 21 U.S.C. 352(o), because you did not notify the agency of your intent to introduce the device into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. 360(k). For a device requiring premarket approval, the notification required by section 510(k) of the Act, 21 U.S.C. 360(k), is deemed satisfied when a PMA is pending before the agency, see 21 C.F.R. 807.81(b). The kind of information you need to submit in order to obtain approval or clearance for your device is described on the Internet at http://www.fda.gov/cdrh/devadvice/3122.html. The FDA will evaluate the information you submit and decide whether your product may be legally marketed.
The devices are misbranded within the meaning of section 502(f)(1) of the Act in that the labeling does not bear adequate directions for use as required by Title 21 Code of Federal Regulations (CFR) section 801.5 and the devices do not meet the requirements for an exemption from section 502(1)(1) under 21 CFR 801.109 and 801.110.
You should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action being initiated by the Food and Drug Administration without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties. Also, federal agencies are advised of the issuance of all 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 (15) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrective action you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.
Your response should be sent to: Todd Maushart, Compliance Officer, Food and Drug Administration, One Montvale Avenue, 4th Floor, Stoneham, Massachusetts 02180. If you have any questions about the content of this letter please contact: Todd Maushart at Phone: (781) 596-7844 or Fax 781-596-7899.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, Form FDA 483 (FDA 483), issued at the closeout of the inspection may be symptomatic of serious problems in your firm's manufacturing and quality assurance systems. You should investigate and determine the causes of the violations, and take prompt actions to correct the violations and to bring your products into compliance.
Sincerely yours,
/S/
Mutahar S. Shamsi
Acting District Director
New England District
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