Automated Ophthalmics, Inc. 6/5/13
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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Baltimore District Office
6000 Metro Drive, Suite 101
Baltimore, MD 21215
Telephone: (410) 779-5455
FAX: (410) 779-5707
June 5, 2013
Mr. Brian Congleton
Automated Ophthalmics, Inc.
6671 Santa Barbara Road, Suite F
Elkridge, Maryland 21075
Dear Mr. Congleton:
During an inspection of your firm located in Columbia, Maryland on February 26, 2013 through March 19, 2013, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures Softips brand tip covers for the Mentor Tonopen. 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 the Softips brand tip covers 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), Part 820.
We received a response from you dated March 22, 2013 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 design requirements are met, as required by 21 CFR 820.30(a). Specifically, your firm has not established design control procedures for Softips that include a design plan, design inputs, design outputs, design reviews, design verification, design validation, and design history file.
We reviewed your firm’s response and conclude that it is not adequate as it does not does not include any proposed timeframes describing when your corrective actions would be completed. In addition, there is no mention of interim actions being taken to ensure that the devices you continue to produce will result in quality product.
2. Failure to inspect, test, or otherwise verify that incoming product conforms to specified requirements, as required by 21 CFR 820.80(b). Specifically, incoming lots of latex tips were not properly inspected, tested, or verified to ensure that they conformed to specified requirements. For example,
a. Latex tip lot 25071 was accepted for use in production on August 22, 2011 despite having more defects than the documented reject level size. The “Latex Tips: Acceptance Testing Worksheet” for lot 25071 documents a total of nine defects and your reject level size was identified as (b)(4).
b. Test results for incoming acceptance of latex tips are not routinely documented. Test results for (b)(4) observed to be missing for lots PJL12/25343 and 25377/POC12.
We reviewed your firm’s response and conclude that it is not adequate. Specific test results need to be recorded. Placing an “x” mark only if the test is not within limits is not acceptable. Proper disposition of material not meeting pre-determined specifications cannot be determined at this time and will need to be verified during a subsequent inspection.
3. Failure to have sampling plans that are written and based on a valid statistical rationale, as required by 21 CFR 820.250(b). Specifically, the reject level for acceptance testing of incoming lots of latex tips and tubes is not based on a valid statistical rationale, nor regularly documented. For example,
a. A reject level size of (b)(4) was identified on the “Latex Tips: Acceptance Testing Summary” sheets for lots 24598 and 25071, as well as the “Tubes: Acceptance Testing Summary” sheet for lot 25142. There is no written justification to explain how this reject level size was determined.
b. The reject level size was not indicated on the “Latex Tips: Acceptance Testing Summary” sheets for lots PJL12/25343 and 25377/POC12, as well as the “Tubes: Acceptance Testing Summary” sheet for lots 25201, 25380, and 25365.
We reviewed your firm’s response and conclude that it is not adequate. The updated version of SOP 29, titled “Acceptance Testing Procedures for Raw Components” (Effective March 21, 2013) included with your firm’s response contains a retesting scheme that is not statistically based or justified. In addition, functional and cosmetic defects are not defined. In your response to this letter, please include a version of SOP 29 that incorporates these comments.
4. Failure to maintain device history records, as required by 21 CFR 820.184. Specifically, there were no device history records for any lots of Softips manufactured since 2010.
The adequacy of your firm’s response cannot be determined at this time and will need to be verified during a subsequent inspection.
5. Failure of management with executive responsibility to review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency, as required by 21 CFR 820.20(c). Specifically, there was no documentation to show that management reviews of the quality system have taken place since 2010. SOP 22, titled “Responsibilities of Quality Assurance” (Effective December 7, 2009) specifies that management review meetings will be conducted (b)(4).
Your firm’s response to this observation appears to be adequate.
Our inspection also revealed that your firm's Softips brand tip covers 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 803 - Medical Device Reporting. Significant violations include, but are not limited to, the following:
1. Failure to develop, maintain and implement written MDR procedures as required by 21 CFR 803.17. For example, during the inspection at your firm, it confirmed that your firm does not have an MDR procedure.
The adequacy of your firm’s response, dated March 22, 2013, cannot be determined at this time. The response included a preliminary plan of action which states that your firm will establish and implement a written MDR procedure separate from its complaint handling procedure that will comply with 21 CFR parts 820 and 803. However, your firm’s response did not include a written MDR procedure.
If your firm wishes to submit MDR reports via electronic submission it can follow the directions stated at the following URL:
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.
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:
U. S. Food and Drug Administration
Baltimore District Office
6000 Metro Drive, Suite 101
Baltimore, Maryland 21215
Refer to CMS case # 395044 when replying. If you have any questions about the contents of this letter, please contact: Ernest Bizjak at (410) 779-5715 or firstname.lastname@example.org
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.
Baltimore District Office