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Executive Summary

Abbott Labs is cited for obstructing FDA inspectors in two "warning" letters sent to the company two days apart from two different FDA district offices. On June 16, FDA's Puerto Rico district office issued a warning letter addressing findings from an inspection of Abbott's Barceloneta tablet manufacturing facility between March 5 and May 10. On June 18, FDA's Chicago district office issued a letter covering violations at the firm's Abbott Park, Ill. plant discovered during a Jan. 4 to March 14 inspection. Among the violations cited in the warning letter issued in Puerto Rico was Abbott's "refusal to permit . . . the review of required records, and the use of photographing equipment." The Chicago district warning letter also cites a refusal by Abbott to allow FDA investigators to review company records; in that case, annual product reviews. The issue of how far reaching the powers are that FDA investigators have at their disposal is currently being debated on Capitol Hill as Congress and the Administration attempt to clarify and expand the agency's enforcement powers. The FDA authorities bill (HR 2597) introduced by Reps. Waxman (D-Calif.) and Dingell (D-Mich.) in June ("The Pink Sheet" June 17, p. 3) addresses, in particular, the taking of photographs by FDA investigators. The bill would provide FDA investigators with the authority to "document or make records of [an] investigation by any reasonable means, including use of photographic equipment, tape and videotape records, and other electronic devices." Also, FDA's pre-approval inspection program has reportedly led to more aggressiveness on the part of agency inspectors, who have generally found less opposition to their requests from companies with a product approval hanging in the balance. FDA sought access to annual product reviews at Abbott's Illinois facility in the context of an evaluation of the production and release of a lot of Pediazole, an oral suspension antibiotic. FDA apparently asked for the annual product reviews for Pediazole when problems were found with Abbott's fill weighing procedures. According to the warning letter, the FDA investigation revealed that during the manufacture of a Pediazole lot, the end- of-fill assay on the sulfasoxizole component of the product "tested at 116.9% potency, which exceeds the 115% limit." The inspection found that Abbott subsequently discarded the last few cases produced of this lot, while releasing the remainder. FDA alleged that Abbott "had not validated fill weight limits to assure that superpotent or subpotent product was not released for distribution." Although Abbott stated in its response to the FD- 483 inspection findings that it had revalidated the Pediazole filling operation, the warning letter notes, the firm "did not submit the documentation to support this conclusion." Inadequate in-process control for tablet weights was also among the GMP problems noted in the FDA warning letter on Abbott's Barceloneta plant. According to FDA district officials, the similarity in the timing of the two warning letters and the issues they address was coincidental and did not reflect coordination between the two districts on the referenced inspections. Other GMP problems noted in the FDA warning letter on Abbott's Puerto Rico plant included: lack of a follow-up investigation when a foreign tablet was found in a batch of the firm's alpha blocker Hytrin (terazosin); and inadequate environmental and laboratory control procedures. While the FDA investigation was in progress, Abbott recalled three lots of dicumarol tablets manufactured at the Barceloneta plant, which, according to FDA's recall listings, were not assured of meeting "dissolution specifications through expiration date." An additional problem noted in the Abbott Park letter involved documentation of reworking in batch records. FDA maintained that batch records for certain lots of the firm's new sleep-aid product, ProSom (estazolam), and colchicine tablets "contained no description of the regrinding of these tablets into granulated particles, mixing the grindings with other granulations, and the recompressing of this material into tablets."

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