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Executive Summary

ALLERGAN STERILITY GMPs, NDA VALIDATION DRAW WARNING LETTER dated Feb. 16 from FDA's San Juan, Puerto Rico district office. The letter stems from an Aug. 24 to Sept. 30, 1992 preapproval inspection of Allergan's Hormigueros, P.R. facility. In addition, three approved products -- the prescription ophthalmic solutions Pred Forte, Lacril and Betagan .5% -- were cited for deficient sterile practices. FDA's San Juan office has received and is evaluating Allergan's response to the warning letter. Allergan sent a letter to FDA Oct. 15 in reply to the agency's Sept. 30 form FDA-483 notice of adverse findings. The firm added that it sent another letter Oct. 27 after it had completed corrective actions, which had required shutting down the plant at one point, and has been requesting an agency reinspection since Jan. 14. The warning letter cites four products with pending NDAs/supplemental NDAs for which "validation lots were not subjected to complete processing." Until observed "deviations" have been corrected, the field office has recommended to the Center for Drug Evaluation and Research that the products not receive approval, the letter notes. In addition, "batch records for validation lots" for the four products "are deficient," the letter states. For three of the four products, the deficiency is due to records that "fail to include actual and theoretical yields of the finished products, or accountability for each lot," the letter adds. The field office said that for one NDA supplement, Allergan has "failed to produce adequate stability data" to support the proposed expiration period for the product. Other observations for the NDA involved missing or inaccurate details of validation testing. Deviations cited for approved products included the failure to "adequately investigate the sterility failures of at least three lots of ophthalmic solutions (Pred Forte, lot 1549TA; Pred Mild, lot 1461TA; and Lacril, lot 257TA)." In addition, compounded ophthalmic solutions have been sterilized "in a manufacturing area not controlled for microbiological contaminants" and a transfer system for solutions "may contribute to an excessive bioburden," the letter states. Evaluation by CDER of sterility standard operating procedures (SOPs) collected during the inspection yielded two further sterility testing concerns, the letter adds. In its March 4 response to the agency, Allergan said that the first observation, regarding air sampling acceptance quality, was caused by a typographical error in its SOP that has been corrected. The second observation, regarding the firm's action level for settling plates, was addressed by the addition of "active air sampling." Finally, the warning letter states that the responsibilities of the facility's quality control units were not in the form of written procedures and that "requirements for the conduct and recording of annual reviews of the quality standards of each drug product by the unit" were not specified.

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