Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
New England District
One Montvale Avenue
Stoneham, Massachusetts 02180
(781) 587-7500FAX: (781) 587-7556
CMS # 309858
VIA UPS Next Day Air
June 11, 2012
Ayn S. Laplant
President and CEO
1 Prestige Lane
Bristol, CT 06010-2658
Dear Ms. Laplant:
During an inspection of your firm, Beekley Corporation, located at 1 Prestige Lane, Bristol, CT on April 16 through May 3, 2012, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures a Bella Blanket. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 321(h), this product is a device because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or is 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 (QS) regulation found at Title 21, Code of Federal Regulations (C.F.R.), Part 820.
On May 24, 2012, we received your undated response concerning our investigator’s observations noted on the Form FDA 483, List of Inspectional Observations that was issued to your facility. We do not consider your response adequate as described below. These violations include, but are not limited to, the following:
1. Failure to establish and maintain procedures for receiving, reviewing and evaluating complaints to determine whether the complaint represents an event which is required to be reported to FDA under 21 CFR Part 803, Medical Device Reporting, as required by 21 C.F.R. § 820.198(a)(3). From December 2011 - January 2012, your firm received at least 11 complaints of artifacts associated with the use of the Bella blanket during mammography procedures. Review of these complaints revealed that you determined an adverse event was not required, however, your firm did not obtain the information necessary to make this determination. For example, you did not assess whether a mammogram needed to be repeated or if the artifacts had the potential for misdiagnosis for each complaint. Your response did not include a revised complaint procedure.
2. Failure to ensure that each lot of finished device meets its acceptance criteria prior its release for final distribution, as required by 21 CFR 820.80(d)(1)). For example, prior to April 2012, your firm was not performing any inspection of your Bella blankets to assure that the material did not interfere with image quality.
3. Failure to document the results of finished acceptance activities as required by 21 CFR 820.80(e)(3). We acknowledge that you have implemented a specification that your Bella blankets to now include a “point” pattern, however you are not recording the results of your inspections on your weekly “Production Report Release approval “ forms. Your response does not address this violation.
Our inspection also revealed that your Bella blanket 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 CFR Part 806 – Reports of Corrections and Removals regulation. Required information regarding device correction and removal actions was not sent to FDA within 10 days of initiating a correction or removal as required by 21 CFR 806.10(b). For example, in January, you conducted a partial removal of three lots of Bella blankets from the market. This information was not reported to FDA within 10 days.
We have reviewed your response and find it inadequate. We understand from your FDA-483 response that you have sent a recall notice to all of your customers via a letter dated May 15, 2012 and will be providing the required information to our recall coordinator by May 31, 2012. However, you have not provided any information or documentation to demonstrate that this violation will not recur.
You should take prompt action to correct the violation(s) addressed in this letter. Failure to promptly correct these violation(s) 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 violation(s), or similar violation(s), 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.
Please direct your response or any questions you may have to Karen Archdeacon, Compliance Officer, Food and Drug Administration, One Montvale Avenue, 4th Floor, Stoneham, Massachusetts 02180. Her telephone number is (781) 587-7491.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violation(s) at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violation(s) 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 violation(s), and take prompt actions to correct the violation(s) and to bring your products into compliance.
Mutahar S. Shamsi
New England District