Resources for Food and Drug Administration (FDA)
Merck warned by FDA over vaccine plant failings
www.in-pharmatechnologist.com The US Food and Drug Administration (FDA) has sent Merck & Co a warning letter saying it has failed to correct a number of manufacturing deficiencies at its main vaccine manufacturing plant in West Point, Pennsylvania.
The agency said Merck had filed an 'inadequate response" to a Form 483 sent to the company several weeks ago, and it now needed to see immediate corrective action.
The agency highlighted several areas in which the plant deviated from good manufacturing practices (GMP). For example, Merck is accused of not investigating why some batches of product were outside of specifications, as well as "failure to maintain production and process control," according to the FDA.
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