Problem the failure to have facilities to repackage beta-lactam

Problem Statement

Attix Pharmaceuticals is a company based in Canada, which
is involved in the repackaging of beta-lactam antibiotic products. On 22nd
June 2015, a warning letter has been issued to them from FDA due to two

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Firstly, it describes the failure to have facilities to
repackage beta-lactam products in a way that prevents cross-contamination
between the ones with penicillin and the ones without, as its personnel and
materials are allowed to move around freely between both facilities. There is
also not enough equipment, along with an absence of air handling systems to
prevent cross-contamination. It is also described in the repackaging logbook
that the company has repacked a number of the mentioned drugs in a facility not
dedicated to manufacturing the antibiotics. Thus, despite the company having discontinued
repackaging penicillin, the risk of the lactam products cross-contaminating
each 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 API
manufacturer to their customers. This is done by having expiry dates on the
certificates of analysis (COA) far exceeding the ones given by the manufacturer,
when the antibiotics are being transferred to the customers without any
scientific explanation. The personnel involved in this practice are no longer
employed by the company, and the specifications for the evaluation of the COA
data for its accuracy and completeness were not in place.

With these violations, the company has been put on FDA
import alert 66-40, which prevents the products to be distributed and are
detained without any physical examination.



When it comes to the patients, there might be some who are
allergic to penicillin, and may have severe responses with an extremely low
presence of penicillin. Therefore, there would have been a high risk of them
having allergic responses if the products have been cross-contaminated with the
others, at levels which bypass general analytical methods. Having wrong expiry
dates would pose a danger to the patients as well as the hospital and clinics
handling them as they would be given these medications.

In terms of company wise, when the APIs are expired, they
would require a retest by the company themselves. Using expired APIs are
harmful, 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 of
segregating the facilities, as its personnel are allowed to move around the
premises without much regulation. Thus, it harms the reputation of the company
due 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 a

Other parties which may have been impacted by the problems
mentioned in the warning letter may be the importers who are involved in the
distribution of the drug to the United States, or anywhere else in the world.
As it is mentioned that the drugs are detained without any physical
examination, they are not allowed to distribute them.  



With these warnings and impacts in tow, the
cross-contamination of drugs as well as having wrong expiry dates have large impacts
should they be distributed to hospitals, and then to patients. These
regulations are put in to ensure the safety of the drug, which is what happened
to Attix Pharmaceuticals.