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Monday, August 29, 2016

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From our friends at PCSC. The Food and Drug Administration’s “Import Division”, on Friday, launch…

Monday, August 29, 2016

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


Import Program

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 …

Sunday, August 28, 2016

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. 

USFDA shoots warning letter to Frontida BioPharm for flouting quality practices - The Economic Times

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.

SecuringIndustry.com - Nigeria warns of counterfeit quinine in market

Friday, August 26, 2016

SecuringIndustry.com - Nigeria warns of counterfeit quinine in market

Nigeria's Federal Ministry of Health has warned that fake quinine products for malaria may be in the supply chain.

SecuringIndustry.com - Weak medicines regulation prompts new WHO strategy for Africa

Friday, August 26, 2016

SecuringIndustry.com - Weak medicines regulation prompts new WHO strategy for Africa

Failures by national regulatory authoritiesare making Africa a fertile ground for poor quality and fake drugs.

SecuringIndustry.com - Pharma serialization snapshot: China

Friday, August 26, 2016

SecuringIndustry.com - Pharma serialization snapshot: China

Our new series on pharma traceability initiatives around the world starts with China, facing major changes.

Injectable Penicillin Products Currently in Shortage

Thursday, August 25, 2016

Injectable Penicillin Products Currently in Shortage

The Food and Drug Administration (FDA) reports that two dosage strengths of Pfizer's Pencillin G Procaine are currently in shortage.

FDA Warns Indian API Maker Unimark for Deviations at Two Facilities | RAPS

Thursday, August 25, 2016

FDA Warns Indian API Maker Unimark for Deviations at Two Facilities | RAPS

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.

Punjab govt asks DRAP to cancel licences of 10 pharma firms

Tuesday, August 23, 2016

Punjab govt asks DRAP to cancel licences of 10 pharma firms

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:…

Monday, August 22, 2016

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

Pills found at Prince's estate contained opioid fentanyl, official says - Monday, Aug. 22, 2016 - InkaBinka: Visual News Summaries in 20 Seconds!

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/IC…

Monday, August 22, 2016

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 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

Monday, August 22, 2016

FDA Publishes Modifications to the List of Recognized Standards http://p0.vresp.com/pZ7YS8

FDA Publishes Modifications to the List of Recognized Standards

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 ...

SecuringIndustry.com - China vows to tighten up food and drug legislation

Monday, August 22, 2016

SecuringIndustry.com - China vows to tighten up food and drug legislation

China has pledged to step up monitoring and enforcement activity to safeguard the food and drug supply chains.

EU Bans Non-Critical, Sterile Products from a Pfizer Site in India Following Joint Inspection | RAPS

Monday, August 22, 2016

EU Bans Non-Critical, Sterile Products from a Pfizer Site in India Following Joint Inspection | RAPS

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.

SecuringIndustry.com - GE patents anti-counterfeit system for bioprocessing kit

Friday, August 19, 2016

SecuringIndustry.com - GE patents anti-counterfeit system for bioprocessing kit

RFID system to detect illegal manufacturing and prevent unauthorized use of bioprocess components.

Second Trafficker Convicted of Distributing Dangerous Counterfeit Viagra and Cialis - Covering Katy

Friday, August 19, 2016

Second Trafficker Convicted of Distributing Dangerous Counterfeit Viagra and Cialis - Covering Katy

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 [...]

Laxachem Organics under import alert | Business Standard

Wednesday, August 17, 2016

Laxachem Organics under import alert | Business Standard

Business Standard, India's leading destination for latest news, analysis and opinion on markets, companies, industry, economy, policy, banking and personal finance.

Statin APIs from Gedeon Richter-linked firm should be prohibited say GMP inspectors

Wednesday, August 17, 2016

Pfizer vancomycin supplier Zhejiang Medicine warned by US FDA

Wednesday, August 17, 2016

Read the EMA's Q&A on GMP Data Integrity http://p0.vresp.com/HXnIT7

Monday, August 15, 2016

Read the EMA's Q&A on GMP Data Integrity http://p0.vresp.com/HXnIT7

Read the EMA's Q&A on GMP Data Integrity

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 ...

DHZC-2 Tablet by Ton Shen Health: Recall - Possible Health Risk

Friday, August 12, 2016

DHZC-2 Tablet by Ton Shen Health: Recall - Possible Health Risk

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.

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