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Druggmpreport

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April 2014

No. 261

Headlines

Full Issue of Drug GMP Report in PDF Format

Download and view the full issue. Read More

FDA to Slash U.S. GMP Inspections by 40 Percent

The FDA is scaling back the number of routine quality inspections it plans to conduct in the U.S. each year by 40 percent in favor of conducting more inspections overseas. Read More

Lawmakers, Industry Criticize FDA Over Compounding Enforcement

Just four months after gaining new authority over compounders, the FDA is facing accusations from lawmakers and the compounding pharmacy lobby that it is overreaching its new role and retroactively applying a new federal law. Read More

Indian API Maker Warned for Recordkeeping Violations

The FDA has warned an Indian active pharmaceutical ingredient manufacturer for a laundry list of severe quality violations, such as failing to test batches and losing records. Read More

Fake Drug Distributors Need Stiffer Penalties: Lawmakers

New authorities granted to the FDA in 2012 that stiffened penalties for drug counterfeiters are failing to curb the problem of fake drugs because they do not apply to distributors of counterfeits. Read More

Pfizer Recalls Antidepressant After Packaging Mishap

Pfizer is recalling three lots of drug products after a packaging mix-up led to a capsule of the wrong drug product in a bottle of an antidepressant. Read More

B. Braun Gets 483 for Poor Inquiries into Batch Problems

The FDA found B. Braun’s investigations into leaky products to be lacking in detail, handing the drugmaker a Form 483. Read More

Advance Pharmaceutical Cited for Lacking Procedures, Testing

OTC drugmaker Advance Pharmaceutical has landed in hot water with the FDA again, getting another Form 483 for various quality issues including a lack of data integrity practices. Read More

LNK Rapped for Unsanitary Processing Conditions

Dirty equipment and a leaky water system led to a Form 483 for drugmaker LNK International. Read More

Hamburg: Global Regulatory Authority in the Works

To help improve drug safety and quality, the FDA and other countries’ drug industry regulators are considering forming a global authority dubbed the International Coalition of Medical Regulatory Authorities, Commissioner Margaret Hamburg says. Read More

Compounders Call for Minimal Restrictions to Ingredients

Compounding pharmacies have flooded the FDA with hundreds of comments seeking to protect access to bulk drug substances they use to make products. Read More

Sun Pharma, Ranbaxy Face U.S. Recalls

Indian generics makers Sun Pharma and Ranbaxy are both facing individual Class II U.S. recalls related to product mixups. Read More

Two Compounders Warned for Mixing Unapproved Drugs

The FDA’s crackdown on compounders continues with two pharmacies receiving warning letters for compounding drugs without a prescription, mixing an unapproved drug ingredient into compounded products and failing to maintain sanitary facilities. Read More

FDA to Hold Public Workshop on Supply Chain Traceability

The FDA will hold a public workshop in early May to discuss the development of standards for the interoperable exchange of information pertaining to prescription drug tracing. Read More

Shire Recalls Gaucher Disease Drug Due to Steel Particles

Shire Pharmaceuticals is recalling three lots of Gaucher disease drug Vpriv after finding stainless steel and barium sulfate particles in a small number of vials. Read More

Sagent Latest Drugmaker To Recall Leaky Injectables

Sagent Pharmaceuticals is the latest drugmaker to recall products with leaky containers, notifying healthcare providers that two lots of its Zoledronic Acid Injection product may not be sterile after finding that four premix bags had been compromised. Read More

Another Indian Company Warned For Extensive Quality Problems

The FDA chastised another Indian drugmaker for poor quality, this time warning active pharmaceutical ingredient manufacturer Smruthi Organics for not protecting raw data and blending out-of-specification batches of active pharmaceutical ingredient with conforming batches. Read More

GSK Recalls Weight Loss Drug, Gets FDA Warning Letter

GlaxoSmithKline alerted consumers that five lots of its OTC weight loss drug Alli may have been tampered with after fielding complaints that a different drug was in some of the bottles. Read More

ISPE Launches Quality Metrics Pilot Program

The FDA, working through the International Society for Pharmaceutical Engineering (ISPE), is launching a one-year pilot program examining the feasibility of collecting manufacturers’ quality metrics, a pivotal piece of the agency’s evolving risk-based inspection program. Read More

Jubilant: FDA Warning to Montreal Plant Is Resolved

The FDA has lifted a February 2013 warning letter issued to Jubilant HollisterStier’s manufacturing facility located near Montreal, Canada, and deemed it acceptable after a follow-up inspection in September 2013. Read More