Inspections, Compliance, Enforcement, and Criminal Investigations
SpecLinc, Inc. 7/20/11
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|New Orleans District|
404 BNA Drive
Building 200 - Suite 500
Nashville, TN 37217
Telephone: (615) 366-7801
FAX: (615) 366-7802
July 20, 2011
WARNING LETTER NO. 2011-NOL-17
UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED
Carney S. Calcutt, Owner
361 Haynes Road
Dyersburg, Tennessee 38024
Dear Mr. Calcutt:
During an inspection of your firm, located at
This inspection revealed your OTREC® otoscope specula are adulterated within the meaning of Section 501(h) of the Act [21 USC 351(h)] as the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation do not conform with the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation found at Title 21, Code of Federal Regulations, Part 820 (21 CFR 820). The violations include, but are not limited to, the following:
1. 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). Such procedures shall ensure complaints are evaluated to determine whether the complaint represents an event which is required to be reported to FDA, per 21 CFR 803, Medical Device Reporting (MDR), as required by 21 CFR 820.198(a)(3). Specifically, your firm has no complaint procedure or files.
Furthermore, your firm failed to review and evaluate all complaints to determine whether an investigation was necessary; and, when no investigation was made, failed to maintain a record including the reason no investigation was made and the name of the individual responsible for the decision not to investigate, as required by 21 CFR 820.198(b). For example, your firm was notified on May 24, 2011, by a pediatric healthcare facility in
2. Failure to establish and maintain procedures for implementing corrective and preventive action (CAPA), as required by 21 CFR 820.100(a). For example, your firm failed to establish procedures for the following requirements:
a. Analyzing processes, work operations, concessions, quality audit reports, quality records, service records, complaints, returned product, and other sources of quality data to identify existing and potential causes of nonconforming product, or other quality problems;
b. Investigating the cause of nonconformities relating to product, processes, and the quality system;
c. Identifying the action(s) needed to correct and prevent recurrence of nonconforming product and other quality problems;
d. Verifying or validating the CAPA to ensure such action is effective and does not adversely affect the finished device;
e. Implementing and recording changes in methods and procedures needed to correct and prevent identified quality problems;
f. Ensuring information related to quality problems or nonconforming product is disseminated to those directly responsible for assuring the quality of such product or the prevention of such problems; and,
g. Submitting relevant information on identified quality problems, as well as CAPAs, for management review.
3. Failure to develop, conduct, control, and monitor production processes to ensure a device conforms to its specifications, as required by 21 CFR 820.70(a). Further, where deviations from device specifications could occur as a result of the manufacturing process, the manufacturer shall establish and maintain process control procedures that describe any process controls necessary to ensure conformance to specifications. Where process controls are needed they shall include:
a. Documented instructions, standard operating procedures (SOPs), and methods that define and control the manner of production;
b. Monitoring and control of process parameters and component and device characteristics during production;
c. Compliance with specified reference standards or codes;
d. The approval of processes and process equipment; and,
e. Criteria for workmanship which shall be expressed in documented standards or by means of identified and approved representative samples.
Specifically, your firm has no records documenting device or component specifications and production processes.
4. Failure to maintain device master records (DMRs) for your OTREC® otoscope specula, as required by 21 CFR 820.181. For example, your firm has not documented, or referenced the location of, the following required information for the devices you manufacture:
a. Device specifications;
b. Production process specifications;
c. Quality assurance procedures and specifications; and,
d. Packaging and labeling specifications.
5. Failure to maintain device history records (DHRs), as required by 21 CFR 820.184. Each manufacturer shall establish and maintain procedures to ensure DHRs for each lot, batch, or unit are maintained to demonstrate the device is manufactured in accordance with the DMR and the requirements of 21 CFR 820. Your firm has no records documenting:
a. The quantity of OTREC® otoscope specula released for distribution;
b. The acceptance records demonstrating the OTREC® otoscope specula are manufactured in accordance with the DMR;
c. The primary identification label and labeling used for each production unit; and,
d. Any device identification and control numbers used.
6. Failure to establish procedures for quality audits and conduct such audits to assure 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. Specifically, you do not have procedures addressing quality audits, nor do you have records documenting quality audits of your facility and suppliers were ever conducted.
7. Failure to establish procedures for identifying training needs and ensuring all personnel are trained to adequately perform their assigned responsibilities, as required by 21 CFR 820.25(b). Specifically, your firm has no training procedures or documentation.
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 FDA without further notice. These actions include, but are not limited to, seizure, injunction, or civil money penalties. Federal agencies are advised of the issuance of all warning letters regarding devices so they may take this information into account when considering the award of contracts. Additionally, premarket applications for Class III devices 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.
Finally, your establishment lacks registration and device listing. Consequently, devices manufactured or distributed by your firm are misbranded under Section 502(o) of the Act [21 USC 352(o)], as they were manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under Section 510 of the Act [21 USC 360]; and not included in a list, as required by Section 510(j) of the Act [21 USC 360(j)].
Please notify this office in writing within 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 recurring. 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: Rebecca A. Asente, Compliance Officer, at the address above. If you have any questions about the content of this letter, please contact: Ms. Asente at (504) 219-8818, extension 104.
This letter is not intended to be an all-inclusive list of 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 Form FDA 483, issued at the conclusion 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 action to correct the violations and to bring your products into compliance.
Monica R. Maxwell
Acting District Director
New Orleans District Office