CAPA flaws result in 4-item 483 for Abbott Diagnostics.(DEVICES)

Abbott Diagnostics International, Barceloneta, Puerto Rico, San Juan District

Abbott Diagnostics International (ADI) was found out of conformance with GMP regulations in its complaint handling and CAPA processes, according to the 483 issued by FDA investigators Wanda Torres and Luis Carrion after an inspection June 7-July 20, 2007.

The FDAers observed that the firm failed to follow its operating procedures that require a Level II complaint investigation for products that do not perform within their labeling. The report noted that the company initially opened a Level I complaint concerning a default interpretation screen on one of its products. That complaint was closed after ADI noted that it had "trained the customer on proper configuration." However, a second similar complaint resulted in a Level II investigation and, more than three months after closing the first complaint, the company "initiated a field action" to correct the problem.

ADI did not always comply with requirements for closing Level I complaints, the investigators stated. For example, a complaint in which "the customer has followed all the recommendations of the quality assurance letter and the problems still persist" was nevertheless closed because, the company's records noted, "the customer has not called back within the period agreed upon. No supplementary investigation is required." Torres and Carrion noted two additional cases in which complaints were closed without appropriate resolution of the problem and/or documentation of actions taken.

The FDA team further found that ADI's evaluation process for Level I complaints involving the possible failure of a device, labeling or packaging to meet any of its specifications did not always include outcomes of action as supplied by the complainant; the extensiveness of the issue; attempts to contact the complaining customer to obtain additional information; and justification of decisions not to investigate complaints.

ADI also neglected to always include the signature of the person who made a decision not to investigate a complaint, the 483 stated. The FDAers noted that two complaints were elevated from Level I to Level II, but there was no documentation about why no Level II investigation was conducted.

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