FDA issues Consent Decree to California Company

FDA announced on November 29 that MBI Distributing, Inc. (MBI), also known as Molecular Biologics, an OTC drug manufacturer of eye drops and other products, has signed a consent decree that requires it to cease manufacturing and distributing drugs until it corrects manufacturing deficiencies and other violations at its Benicia, California facility.

This action is a result of FDA having determined that the firm has been manufacturing eye drops in a manner that does not conform to FDA's current good manufacturing practice requirements. The firm has not corrected violations noted during inspections, despite Agency efforts to have the company achieve compliance.

Among other things, at FDA's most recent inspection, the firm lacked manufacturing controls to ensure that its eye drops were sterile.

Here's another example of what can happen when GMP is not applied and followed.

Read FDA's Press Release with more information about this action.
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Click on Resources, then scroll down to Timely Resource Articles.

Training Tip

During your GMP training sessions, have small groups of people discuss the impact an action like this can have on a company.

Answers may include things like:

- Stock price drops (causing stockholders to get cranky and put pressure on management to improve performance).
- Reputation of the company is affected, possibly resulting in decreased sales.
- Lost revenue and possibly lost jobs.
- Budget tightening at the company.
- More FDA scrutiny.
- Morale could decrease within the company.

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