From our friends at PCSC. The Food and Drug Administration’s “Import Division”, on Friday, launched a revamped website designed to make it easier to access information on import rules and requirements for specific commodities. The FDA import site offers insight into common customs entry errors, answers many questions regarding imports of FDA-regulated products, and provides contact information to reach customer service agents at local ports and at the FDA headquarters. See: http://www.fda.gov/ForIndustry/ImportProgram/default.htm
All products regulated by the Food and Drug Administration must meet the same requirements, whether imported from abroad or produced domestically. The job of protecting consumers includes an ever-increasing need to oversee imports, which have been increasing by 10-15 percent per year for the ...
The letter disclosed that the unit's vice president of quality repeatedly denied any knowledge of clonidine API supplier's recall, even though email evidence collected during the inspection showed that this individual had been notified of the recall as early as July 16, 2014.
It said the site officials were aware that benzophenone had leached into tablets from the ink and varnish on the primary container label, but there was no recall of the lot.
Nigeria's Federal Ministry of Health has warned that fake quinine products for malaria may be in the supply chain.
Failures by national regulatory authoritiesare making Africa a fertile ground for poor quality and fake drugs.
Our new series on pharma traceability initiatives around the world starts with China, facing major changes.
The Food and Drug Administration (FDA) reports that two dosage strengths of Pfizer's Pencillin G Procaine are currently in shortage.
The US Food and Drug Administration (FDA) has issued a warning letter to active pharmaceutical ingredient (API) maker Unimark Remedies Ltd. for poor manufacturing controls and data integrity issues at two of its facilities in India.
Complaints were lodged on the basis on manufacturing, buying and selling substandard medication.
Pills found at Prince's estate were counterfeit and contained opioid fentanyl, official says http://www.inkabinka.com/story/b6c39c38-d1bc-4995-9e89-267a2abfa682?sid=d36c8494-e6aa-4551-844d-4e778895478f
Several pills taken from Prince's estate in Paisley Park after his death were counterfeit drugs that actually contained fentanyl.
EMA Publishes Update to “Quality of Medicines Questions and Answers Part 1" http://p0.vresp.com/ICofeV
EMA Publishes Update to “Quality of Medicines Questions and Answers Part 1". EMA published a new question and answer on July 29, 2016 regarding Active Substance - Active Substance Master File Procedure. The “Quality of Medicines Questions and Answers Part 1” addresses a number of questions that ...
FDA Publishes Modifications to the List of Recognized Standards http://p0.vresp.com/pZ7YS8
FDA Publishes Modifications to the List of Recognized Standards. The FDA has modified the list of standards FDA recognizes for use in premarket reviews (“FDA Recognized Consensus Standards”). Specifically, this publication announces the following modifications related to standards for ...
China has pledged to step up monitoring and enforcement activity to safeguard the food and drug supply chains.
A statement of noncompliance released by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Friday effectively bans in the EU medicinal products considered non-critical to public health from Pfizer's Irungattukottai, India-based site following an inspection with four regulators.
RFID system to detect illegal manufacturing and prevent unauthorized use of bioprocess components.
HOUSTON – A 47-year-old Pennsylvania man has entered a guilty plea to charges related to a conspiracy to traffic in counterfeit Viagra and Cialis and for smuggling, trafficking and introducing the misbranded prescription drugs into interstate commerce, announced U.S. Attorney Kenneth Magidson along with Acting Special Agent in Charge Charles L. Grinstead of the Food [...]
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Read the EMA's Q&A on GMP Data Integrity http://p0.vresp.com/HXnIT7
EMA Questions and Answers: Good Manufacturing Practice - Data Integrity Q&As Added. The EMA has released new GMP guidance to ensure the integrity of data that are generated in the process of testing, manufacturing, packaging, distribution and monitoring of medicines. EMA's GMP/GDP Inspectors ...
Tablets have the potential to be contaminated with elevated levels of lead, a naturally occurring element which can affect multiple body system and particularly harmful to young children.