Inspections, Compliance, Enforcement, and Criminal Investigations
Huestis Machine Corporation 8/6/13
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|New England District Office|
One Montvale Avenue, 4th floor
Stoneham, MA 02180
CMS # 398551
UNITED PARCEL SERVICE
August 6, 2013
Mr. Krishnan Suthanthiran, President
Best Medical International
7643 Fullerton Road
Springfield, VA 22153
Dear Mr. Suthanthiran:
During an inspection of your firm located in Bristol, Rhode Island on April 23 through May 13, 2013 an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures X-ray collimators, radiotherapy simulators and Universal Urology Exam Chairs/Tables. 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 any 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), Parts 820 and 1002. These violations include, but are not limited to, the following:
1. Failure to ensure that all equipment used in the manufacturing process meets specified requirements and is appropriately designed, constructed, placed, and installed to facilitate maintenance, adjustment, cleaning and use as required by 21 CFR 820.70(g)
For example, there is no documentation of installation for the (b)(4) used for Collimator Leakage Testing (Ray Proofing: X-ray output verification). The Engineering Manager said the system has been in use for more than a year: he was not sure if it has been in use for more than two years. (b)(4) collimators were sold in 2012.
2. Failure to adequately established procedures for receiving, reviewing and evaluating complaints by a formally designated unit as required by 21 CFR 820.198 (a).
For example, your firm was not able to provide a specific procedure utilized for the handling of consumer complaints.
Also, a review of 53 reports monitored by your firm using Problem Log/Return Authorization Entry Forms revealed at least 18 of these reports involved performance issues that should have been identified as complaints, including one report involving collimator blades opening during exposure, which could result in a patient being exposed more radiation than intended; one report that has been open for over 11 months; and three reports involving collimators that have been open for over 7 months.
In addition, responsibilities for making complaint, MDR and CAPA determinations are not accurately defined in your firm’s work instruction, WI-14-003.
3. Failure to adequately document acceptance activities as required by 21 CFR 820.80 (e).
For example, fourteen of fifteen collimator in-process inspection records contained in Work Order 013035-000 were filled out with passing results, initialed, and signed prior to the testing being conducted.
4. Failure to adequately maintain a device history record (DHR) as required by 21 CFR 820.184.
For example, the DHR for the Radiotherapy Simulator, Serial # SIM-4250-345, is inadequate, in that, results are not recorded or instructions are incomplete for eight performance checks in the Setup and Adjustment Guide for the CPI generator, Image Intensifier, and Camera for the Radiotherapy Simulator.
Also, The DHRs for collimators are incomplete. The (b)(4) used to measure the X-ray output during the Collimator Aluminum Equivalence test for each collimator is not recorded.
Additionally, the DHR for Universal Urology Exam Chairs/Tables, Model UCT 100, WO 004999-000, is inadequate. Documentation regarding the manufacture of 2 exam chairs, in that, your firm was not able to provide any documentation.
5. Failure to adequately maintain a device master record (DMR) as required by 21 CFR 181.
For example, the DMR for x-ray collimators is inadequate:
a) The Collimator Leakage Test, CM-21-028, Rev B, does not reflect the actual process.
b) A signed Setup Interface could not be found for the CM-21-028 Software Performance Verification Procedure in the Collimator Technical Manual.
6. Failure to suitably design a building to prevent mix-ups and assure orderly handling of product as required by 21 CFR 820.70 (f).
For example, products are not stored in a manner to prevent mix-ups. On April 24, 2013, collimators awaiting repair were stored in multiple areas next to both products destined for scrapping and products to be built.
In addition, the Open Problem Log/RA Entry forms do not accurately record where the collimators are stored. On 4/24/13, six collimators were found in Area 5 and seven collimators were found in Area 6, although the form shows that they had been moved to the non-conforming area. Also, two collimators were found in the non-conforming area although the forms indicated the units had been tested and accepted during January of 2013.
7. Failure to ensure individuals that conduct quality audits are not directly responsible for matters being audited as required by 21 CFR 820.22.
For example, in 2012, the your firm’s Assistant Quality Manager and the Quality Control Inspector conducted internal quality audits in areas for which they were responsible.
This is a repeat observation from the June 2011 inspection of your firm.
Your firm 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 FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties. Also, 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 violations 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, as well as 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. Your firm’s response should be comprehensive and address all violations included in this Warning Letter.
Your firm’s response should be sent to the New England District Office. Refer to the CMS case # 398551 when replying. If you have any questions about the contents of this letter, please contact: Diane M. Prince at 781-587-7442.
In addition, this letter is to advise you of your failure to comply with the Federal Food, Drug, and Cosmetic Act (Act), Subchapter C, Electronic Product Radiation Control, Section 538(a) [U.S.C. § 360oo(a)].
The following failures to comply with the regulations covering records and reports were observed:
1. Failure to submit annual reports for products requiring one to be submitted, as required by 21 CFR 1002.13.
For example, you have not submitted annual reports for the following products identified as containing an X-ray tube and/or laser:
a) Radiotherapy Simulator that contains an X-ray tube and a collimator. In 2012, your firm sold (b)(4) of these devices.
b) Collimators that contain lasers. In 2012, your firm sold (b)(4) of these devices.
c) Room lasers that are sold with the Radiotherapy Simulators. In 2012, your firm sold four of these products
2. Failure to forward all distribution information that you have collected (pursuant to 21 CFR 1002.40) to the manufacturer and failure to preserve such information as required by 21 CFR 1002.41(a) (1).
For example, your firm has not forwarded laser distribution information to the manufacturer of the (b)(4) lasers distributed with the radiotherapy simulators, and your firm was not able to locate a written agreement with the manufacturer.
Failure to comply with Section 538(a) of the Federal Food, Drug, and Cosmetic Act, Chapter V Subchapter C -Electronic Product Radiation Control (the Act), prohibits any manufacturer from ce1iifying or introducing into commerce electronic products, such as x-ray collimators and lasers, which do not comply with the standard. This section also prohibits any manufacturer from failing to establish and maintain required records or to submit required reports.
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 propt actions to correct the violations and bring the products into compliance.
Joseph Matrisciano Jr.
Acting District Director
New England Distict