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This article was originally published in The Gray Sheet

Executive Summary

ALLERGAN REVISING SOPs FOR IOL PROCESS VALIDATION at its Anasco, Puerto Rico manufacturing facility, the company says in a March 30 response to an FDA warning letter. In the warning letter, dated March 19, FDA takes issue with Allergan Medical Optics' Dec. 15 response to an FD-483 resulting from a November inspection. The agency maintains that the December letter's discussion of a citation regarding process validation did "not address the noted violation as observed by the investigator." Allergan states in the March 30 letter that it intends to review and revise the "current standard operating procedure that describes process validation" for intraocular lenses by April 16. As a part of the revision, the engineer responsible for the validation will be required to "review all manufacturing documents, including manufacturing instructions, inspection criteria and specifications affected by the validated changes," and include them in a validation file. The implementation of any changes are to "be made upon full review and sign-off of an Engineering Change Request (ECR) according to SOP." In addition, the ECR process will be modified to include a mandatory "training session of manufacturing personnel for any validated process, material or specification changes." The training will be documented in both the ECR file and the employee training record, Allergan says. The warning letter also questions the company's answer to a violation cited in the FD-483 regarding the accessibility of records at the manufacturing site. FDA states: "The response does not accurately characterize the difficulties experienced by the investigator in obtaining copies of records required to be 'reasonably accessible'" in GMP regs. However, FDA adds that a proposed Allergan document imaging project, which would allow electronic access to records not maintained on site, "appears to adequately address record accessibility, as long as the system works." Allergan says that the "difficulties" encountered by FDA were attributable to the company's retention of "certain records" at its headquarters in Irvine, California, rather than on-site in Anasco. While the company contends that "this practice is permissible" under FDA regulations, it intends to make several "improvements" so that records maintained at the Irvine facility are available "to FDA inspectors of the Anasco facility." For example, current device master records and complaint files presently maintained at the manufacturing site in Anasco are to be "available immediately for inspection by an appropriate FDA official," while DMRs and device history records currently maintained in Irvine are to be made available to FDA "within 24 hours of a request" for inspection. The delay, the company maintains, "is fully justified, given the logistics of sending such documents" from California to Puerto Rico. In the instances where the 24 hour deadline cannot be met, the company intends to "work in close cooperation with the field inspector to achieve an expedited and mutually acceptable timetable for production of such documents." Allergan also says that it intends to create a "computerized document management system in the Anasco facility which will allow immediate electronic access" to records stored at Irvine. The system, which is to be "validated prior to implementation in accordance with a validation protocol," is to include "all DHRs and DMRs from 1993 onward." Earlier documents will continue to be maintained in a manual system.

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