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Home » Topics » Pharmaceuticals » GMPs

GMPs
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Compounder Warned for Long List of GMP Violations

June 30, 2017
Empower failed to establish and follow written procedures for microbiological contamination. Read More

FDA Relaxes 14-Year-Old Recommendations for Medical Gas GMP Compliance

June 30, 2017
The previous version, issued in 2003, required that each container bear an expiration date, based on related storage conditions. Read More

Compounder Warned for Long List of GMP Violations

June 29, 2017
A Texas-based compounder specializing in hormone therapies for men and women was warned by the FDA for extensive cGMP violations as well as producing drugs for which there was no valid prescription. Read More

FDA Relaxes 14-Year-Old Recommendations for Medical Gas GMP Compliance

June 28, 2017
The FDA replaced its 14-year-old draft guidance on cGMPs for the production of medical gases, relaxing some recommendations on expiration dating and warehousing procedures. Read More

Indiana Compounder Indicted on Conspiracy, Drug Potency

June 28, 2017
According to the indictment, at least three infants experienced life-threatening effects. Read More

Indiana Compounder Indicted on Conspiracy, Drug Potency

June 26, 2017
Pharmakon Pharmaceuticals executives routinely sent drugs to hospitals without waiting for test results confirming the potency of the drugs matched their labels, and when results showed the strength was often nearly double what it should have been, covered up the error and lied to FDA investigators rather than notifying the FDA or customers, according to a 10-count federal indictment. Read More

Indian Drugmaker’s Products Banned from U.S. Market after Drug Shortage Ends

June 23, 2017
Malaria treatment is the only exemption to the ban. Read More

Indian Drugmaker’s Products Banned From U.S. Market After Drug Shortage Ends

June 21, 2017
The FDA has broadened its import ban against Indian manufacturer Ipca Laboratories to include four drugs previously exempted due to shortage. Only Ipca’s anti-malarial API remains exempted and can be imported into the U.S. Read More

Connecticut Compounder Warned on Unsanitary Conditions and More

June 20, 2017
FDA warned Beacon Prescriptions recently for unsanitary conditions. Read More

FDA Plans Public Workshop to Evaluate Studies of Abuse-Deterrent Opioid Use

June 19, 2017
Two-day meeting will address better uses of data, methodology. Read More

Connecticut Compounder Warned on Unsanitary Conditions and More

June 15, 2017
Beacon Prescriptions, a compounding pharmacy in Southington, Conn., was warned by the FDA for unsanitary conditions and other federal violations, according to a letter sent earlier this month. Read More

Supplement Company Draws Warning Over GMPs

May 31, 2017
The facility lacked specifications for quality control in its supplement manufacturing or packaging operations. Read More
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