OTC Drug Manufacturer Warned On GMP Problems FDA Initially Found In 2010
"In response to each of those inspections and compliance actions taken against your firm, you proposed specific remediations to fully address the violations," says FDA in warning letter to TG United. Firm in 2013 recalled 44 products – totaling some 688,000 containers plus 2.53m pills or tablets distributed in bulk – due to GMP deviations.
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Examples of unfinished business from 2019 include no legislation passed to reform OTC monograph program; FDA putting off until May the planned publication of an NPRM to allow firms to submit OTC NDAs with extra-label information to help guide consumers' self-selection; and no OTC naloxone for opioid overdose approved even after FDA's unprecedented step of developing model DFLs sponsors could use for their own label comprehension studies.
The “Contract Manufacturing Arrangements for Drugs: Quality Agreements” draft guidance describes how parties involved in contract manufacturing of drugs can employ quality agreements to delineate their responsibilities and ensure drug quality, safety and efficacy.
Recalls reported by FDA for OTC drugs, nutritionals and personal care products.