Drug GMP Report

Manufacturers will get the FDA’s first general draft guidance on cross-contamination this year, CDER’s Office of Compliance told DGR.

The FDA has warned McNeil Consumer Healthcare for being too slow to alert the FDA and consumers to trace amounts of a chemical wood-treatment in some of its products, including its OTC drug Tylenol.

Sunrise Pharmaceutical received a warning letter after manufacturing some of its products with excess active pharmaceutical ingredient (API) without justification in its batch records.

FDA investigators have found Watson Laboratories’ Davie, Fla., facility failed to submit data in an ANDA showing its 30-mg amphetamine extended-release capsules failed a bioequivalency study.

Ben Venue Laboratories has received an FDA Form 483 with nine observations relating to GMP violations, including equipment-cleaning issues.

Denison Pharmaceuticals received an FDA Form 483 after an inspection found floors in the warehouse covered with debris and walls with exposed insulation.

Operators at Impax Laboratories allowed product powder to flow onto a dish outside the plastic enclosure of equipment during a compression process, according to a Form 483 sent to the company.

Drugmakers that are the sole or primary source for certain key drugs need to be able to continue production during a pandemic and should create emergency production plans that can delay or modify some GMPs to ensure production, a draft guidance says.

Hospira will perform fill-finish manufacturing services for several Genzyme products as Genzyme works to recover from a manufacturing halt and two recent contamination issues.

Drugmakers will have to continue to include an environmental assessment (EA) of their manufacturing operations in drug applications or apply to waive the review if the Office of Management and Budget (OMB) approves the FDA’s request to renew the industry reporting requirement.

A final FDA GMP guidance recommends a new method for testing drugs’ dissolution rates.

Teva Pharmaceutical Industries has asked the FDA to allow it to amend its manufacturing process to help alleviate a shortage of its herpes treatment acyclovir.

The FDA has warned GDMI, which makes OTC antifungal treatments, about significant GMP violations at a facility in Texas, including flaws in sanitation and training.

Ranbaxy Laboratories subsidiary Ohm Laboratories has received a warning letter for GMP violations at its facility for making oral solutions.

A Hong Kong committee on drugs, set up in the wake of safety concerns about pharmaceuticals produced locally last year, has issued 75 recommendations including meeting international GMP standards and stricter postmarket surveillance of high-risk products.

Drugmakers should not respond with a single comprehensive plan to a Form 483 with multiple observations, an expert says.

A consumer lawsuit against KV Pharmaceutical over GMP violations has been dismissed because only the federal government has the authority to enforce the Federal Food, Drug and Cosmetic Act (FDCA), a court says.

Nearly five months after the FDA began its closeout letter program, the agency has issued only one letter for a medical product, leaving companies wondering when they can expect to receive the official stamp of approval that clears them of concerns raised in warning letters.

The FDA has sent Lupin Pharmaceuticals an official communication that the company resolved an earlier warning letter to its Mandideep, India, facility.