Inspections, Compliance, Enforcement, and Criminal Investigations
Advanced Medical Optics Uppsala Ab, 9/18/09
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|10903 New Hampshire Avenue|
Silver Spring, MD 20993
SEP 18 2009
VIA FEDERAL EXPRESS
Managing Plant Director
Advanced Medical Optics Uppsala Ab
Dear Mr. Call:
During an inspection of your firm located in Uppsala, Sweden on March 16 through March 19, 2009, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures Healon®, Healon GV®, Healon5® and Healon®D Sodium Hyaluronate Ophthalmic Viscoelastic Devices. 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 (QS) regulation found at Title 21, Code of Federal Regulations (C.F.R.), Part 820. We received two partial responses from Ewa-Lena Hartman, Director of Quality Operations, dated April 17, 2009 and July 14, 2009, concerning our investigator's observation noted on the Form FDA 483, List of Inspectional Observations that was issued to you. We address this response below, in relation to the following noted violation:
Failure to adequately ensure that when the results of a process cannot be fully verified by subsequent inspection and test that the process shall be validated with a high degree of assurance and approved according to established procedure, as required by 21 C.F.R. 820.75(a).
For example, your firm failed to perform and document equipment cleaning validation for the production of Healon D ophthalmic viscoelastic devices.
We have reviewed your response and have concluded that it is inadequate because you do not intend to complete your validation of the equipment cleaning process for the production of Healon D ophthalmic viscoelastic devices for 10-15 months, pending the completion of the root cause investigation from the recall of Healon D, Lot UD30654.
Given the serious nature of the violation of the Act, Healon D ophthalmic viscoelastic devices manufactured by your firm are subject to refusal of admission under section 801(a) of the Act, 21 U.S.C. § 381(a), in that they appear to be adulterated. As a result, FDA may take steps to refuse these products, known as "detention without physical examination," until these violations are corrected. In order to remove the devices from detention, you should provide a written response to this Warning Letter as described below and correct the violation described in this letter. We will notify you if your response is adequate, and we may need to re-inspect your facility to verify that the appropriate corrections have been made.
Also, U.S. federal agencies arc 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 violation, including an explanation of how you plan to prevent this violation, or similar violation, 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 provide a translation of documentation not in English to facilitate our review.
Your response should be sent to: Ronald L. Swann, Chief, Dental, Ear, Nose, Throat, and Ophthalmic Devices Branch, 10903 New Hampshire Avenue, Building 66, Room 3534, Silver Spring, Maryland, 20993, U.S.A. If you have any questions about the content of this letter please contact: Ronald L. Swann at 301-796-5770 or by fax 301-847-8137.
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 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 system. You should investigate and determine the causes of the violation, and take prompt actions to correct the violation and to bring your products into compliance.
Timothy A. Ulatowski
Office of Compliance
Center for Devices and