The FDA has been issuing warning letters to companies marketing dietary supplement products containing N-Acetyl Cysteine (NAC). Read our blog to learn more.
N-Acetyl Cysteine, or simply NAC, is a powerful antioxidant and semi-essential amino acid.
It’s considered semi-essential because your body can produce it from other amino acids, namely methionine, and serine.
It becomes essential only when the dietary intake of methionine and serine is low.
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Medical device manufacturers receive observations (Form 483) and / or warning letters on completion of USFDA Audit.
The document outlines any violations of Good Manufacturing Practices (GMP’s) such as the facility, equipment, processes, controls, products, employee practices or records.IZiel has successfully assisted medical device companies to resolve these observations with efficiency and accuracy.https://iziel.com/form-483-remediation/
This whitepaper documents ComplianceQuest’s position regarding compliance to Electronic Records; Electronic Signatures 21 CFR Part 11.
Some industrial segments need to be exponentially stringent with their quality and compliance processes compared to other segments.
The Life Science industry is part of this stringent segment.
They need to ensure the quality of their products because they deal with human safety.
The accuracy and efficiency of their work could well be a matter of life and death.