Problem StatementAttix Pharmaceuticals is a company based in Canada, whichis involved in the repackaging of beta-lactam antibiotic products. On 22ndJune 2015, a warning letter has been issued to them from FDA due to twoviolations.
Firstly, it describes the failure to have facilities torepackage beta-lactam products in a way that prevents cross-contaminationbetween the ones with penicillin and the ones without, as its personnel andmaterials are allowed to move around freely between both facilities. There isalso not enough equipment, along with an absence of air handling systems toprevent cross-contamination. It is also described in the repackaging logbookthat the company has repacked a number of the mentioned drugs in a facility notdedicated to manufacturing the antibiotics. Thus, despite the company having discontinuedrepackaging penicillin, the risk of the lactam products cross-contaminatingeach other is high. Secondly, after a review of the company’s internal audit,it shows to have failed to transfer expiry dates received from the APImanufacturer to their customers. This is done by having expiry dates on thecertificates of analysis (COA) far exceeding the ones given by the manufacturer,when the antibiotics are being transferred to the customers without anyscientific explanation. The personnel involved in this practice are no longeremployed by the company, and the specifications for the evaluation of the COAdata for its accuracy and completeness were not in place.
With these violations, the company has been put on FDAimport alert 66-40, which prevents the products to be distributed and aredetained without any physical examination. ImpactsWhen it comes to the patients, there might be some who areallergic to penicillin, and may have severe responses with an extremely lowpresence of penicillin. Therefore, there would have been a high risk of themhaving allergic responses if the products have been cross-contaminated with theothers, at levels which bypass general analytical methods. Having wrong expirydates would pose a danger to the patients as well as the hospital and clinicshandling them as they would be given these medications. In terms of company wise, when the APIs are expired, theywould require a retest by the company themselves. Using expired APIs areharmful, as it has a higher risk of harming them, and it is unethical to do so.It can also be said that the company is not strict enough in terms ofsegregating the facilities, as its personnel are allowed to move around thepremises without much regulation.
Thus, it harms the reputation of the companydue to not only the possible harms they could have brought on their customers,but also on their strictness. This may have an impact on their business as awhole. Other parties which may have been impacted by the problemsmentioned in the warning letter may be the importers who are involved in thedistribution of the drug to the United States, or anywhere else in the world.As it is mentioned that the drugs are detained without any physicalexamination, they are not allowed to distribute them. ConclusionWith these warnings and impacts in tow, thecross-contamination of drugs as well as having wrong expiry dates have large impactsshould they be distributed to hospitals, and then to patients. Theseregulations are put in to ensure the safety of the drug, which is what happenedto Attix Pharmaceuticals.