| Public Health Service Food and Drug Administration |
| San Juan District Compliance Branch 466 Fernandez Juncos Avenue San Juan, Puerto Rico, 00901 Compliance Branch Telephone: 787-474-9500 FAX: 787-729-6658 |
Department of Health and Human ServicesWARNING LETTER
11-SJN-WL-02
December 21, 2010
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Ms. Andrea Saia, CIBA Vision CEO
CIBA Vision Corporation
11460 Johns Creek Parkway
Duluth, GA 30097
Dear Ms. Saia:
During an inspection of your firm located at El Jibaro Industrial Park Lots 1 & 2, Route 173, Km 1.1, Cidra, Puerto Rico conducted from 07/21/10 through 09/02/10, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures Class II and Class III soft contact lenses. 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 found 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 a written response signed by Ms. Gladys Melendez, General Manager and by Mr. Pedro Melendez, Site QA Head, dated 09/23/10, concerning our investigator’s observations noted on the Form FDA 483, List of Inspectional Observations that was issued to your firm on 09/02/2010. We address these responses below, in relation to each of the noted violations. These violations include, but are not limited to, the following:
1. Failure to validate with a high degree of assurance and approve according to established procedures the results of a process which cannot be fully verified as required by 21 C.F.R. § 820.75(a).
Specifically:
Except for your SoftPerm products, your firm failed to provide documented evidence to support that the sample size used for the bioburden and sterility tests conducted on all your products, represents the product inside the vial including the buffered solution. In addition, you also failed to provide data that could support that the actual methods you used for the recovery of microorganisms from your products during bioburden determination and sterility tests are effective.
You indicated in your response to the FDA-483 your intention to validate the bioburden and sterility test methods. Please include in your response to this letter a summary report of the outcome of these validations and a timeline for completion of this project. In addition, if as a result of your validation studies you have to develop new methods, please include an assessment of how any changes performed or deficiencies disclosed during your validation studies may impact distributed products.
2. Failure to identify the action(s) needed to correct and prevent the recurrence of nonconforming product and other quality issues. In addition, procedures addressing the identification of corrective and preventive actions were not implemented as required by 21 C.F.R. § 820.100(a)(3).
Specifically:
During the period of March through May 2010 your firm opened three CAPAs to address issues related to distributed products which had labeling inconsistencies. These deficiencies were not detected by your quality inspectors even though your procedures require that QA inspectors verify if the label rolls have the correct expiration date, bar code reading, and that the product complies with specifications. We found that you failed to implement adequate corrective and preventive actions when you opened CAPA (b)(4) in March 2010 to avoid the recurrence of labeling problems. You had to open two additional CAPAs (CAPA (b)(4) and CAPA (b)(4)) in April and May of 2010 to address additional non-conformances related to the same issue.
You indicated in your written response that you conducted a detailed investigation for each of the three non-conformances cited in the FDA-483 and that corrective actions were defined. Nevertheless, the fact that you had to open three CAPAs to address similar issues shows that your corrective actions were ineffective to correct the problem. You also indicated that you were in the process of conducting a comprehensive assessment of labeling issues. Please include with your response to this letter the results of your assessment including identified corrective actions with established timeframes for implementation for our review. The inaccurate labeling of distributed products is a recurrent deficiency which was also identified in our 2009 inspection.
In addition, our inspection covered your investigation into the root cause of several stability sterility failures associated to (b)(4) (Stopper Lot # (b)(4)) of your product SoftPerm contact lenses. These stability results are related to a new stability study conducted by your firm after you made a change to your approved container stopper. Your investigation concluded that all failures were false positives associated to poor aseptic techniques and a contamination of the stability chamber. Our evaluation found that you did not provide sufficient evidence during the inspection that could support your conclusion that all sterility failures were false positives. The sterility failures were obtained by two different contract laboratories, (b)(6) and (b)(6), which investigated the Out of Specification Results (OOS) and were unable to relate the failures to a laboratory error. Your investigation indicates that audits conducted at these contract laboratories in 2008 demonstrated poor aseptic techniques.
We find objectionable that despite these findings, you continued using these contract laboratories to conduct the sterility testing of all your products without ensuring that they had implemented adequate corrective actions to the deficiencies identified during your audit. In addition, you failed to investigate a sterility failure associated to (b)(4) (Stopper Lot # (b)(4)) which failed at 18 months real time even though you distributed this lot to the market. This lot, besides having a sterility stability failure associated to it, also failed the osmolality test. (b)(4) and (b)(4) failed the (b)(4) tests. You acknowledge the (b)(4) failures but concluded that it did not represent harm to patients.
We acknowledge that you have decided to discontinue manufacturing this product. Nevertheless, we are concerned with the quality of distributed Lot# (b)(4) because you do not have stability data that could show that the change of the product stopper does not affect the quality of your product.
In your response to this letter, please explain how you can demonstrate that the quality of your distributed Softperm lenses was not affected with the use of the new stoppers when you do not have stability data that could support this change. Please provide a list to include all the lot numbers, expiration dates, and amount distributed for product that was manufactured and distributed using the new stopper. During the inspection, you were unable to provide this information which is a concern to us because it may demonstrate that your distribution records are not maintained in accordance to 21 CFR 820.160.
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 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.
This letter is not intended to be an all-inclusive list of the 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 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 violations, and take prompt actions to correct the violations and bring your products into compliance.
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 violations, or similar violations, 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.
Your response should be sent to: Maridalia Torres, District Director. If you have any questions about the content of this letter please contact: Margarita Santiago, Compliance Officer, at 787-474-4789.
Sincerely,
/s/
Maridalia Torres
District Director
San Juan District
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