The FDA’s inspection revealed the lab’s president and owner, James Stephen, operated the microbrewery where his pharmaceutical firm tested over-the-counter drugs and products. From Sept. 18 to Oct. 10, inspectors found microbiology lab media stored in the same area brewery materials were stored, which the FDA said posed “unacceptable risks” like contamination.
In its warning letter, the FDA noted other significant violations of standard manufacturing practices pertaining to the lab’s scientific methods, facilities, processes, packaging and storing.
The FDA found similar deficiencies at Pharmaceutical Laboratories and Consultants dating back as far as 2007. The agency said if the pharmaceutical lab fails to correct the violations, legal actions may follow without further notice.
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