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The FDA’s Division of Pharmaceutical Quality Operations hit repackager Loxha with a warning letter for lacking stability data and other GMP failures. Read More
A drugmaker in the Czech Republic was listed on the EudraGMDP inspection database for serious deficiencies at its Prague facility including the presence of mold and dead insects. Read More
EPH Technologies was slapped with an FDA warning letter for marketing unapproved drugs, including a product it claimed would relieve opioid withdrawal symptoms.
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“You can only rely on a COA for other component attributes by validating the supplier’s test results at appropriate intervals,” the FDA said. Read More