The FDA has told West-Ward Pharmaceuticals it needs to fix manufacturing and testing issues that have permitted the release of lithium and digoxin tablets that fail size specifications.
The Feb. 3 letter, posted by the FDA on Tuesday, says the inadequate testing by the contract manufacturer at its Eatontown, NJ, plant allows the release of batches of lithium carbonate extended release tablets, USP 450 mg, that are outside specifications for thickness and hardness. The company needs a follow-up investigation to determine the root cause of the problem, according to the letter.
There also have been issues in achieving the proper dissolution rate for the lithium carbonate tablets, a slow release version often used with bipolar patients. West-Ward has changed the manufacturing process for the drug a number of times since Nov. 25, 2008, but has failed to document the effects of those changes, the FDA says. As part of the remedy, the company may need to do process validation studies, the agency adds.
West-Ward did not respond to a request for comment from FiercePharmaManufacturing.
The FDA warning letter notes West-Ward agreed to suspend production of the lithium tablets while it assesses the process changes. The warning also takes West-Ward to task for not indicating what it would do for batches of the drug already released that may be out of tolerances.
There also have been problems with weights of digoxin 0.125-mg tablets, the letter notes: "Your response failed to address this significant quality problem for Digoxin tablets. Additionally, your response does not address your failure to implement a global electronic quality management system (QMS) system that you committed to implement as a corrective action in response to deficiencies in your firm's handling of investigations noted during our February 8 to March 1, 2010 inspection of your firm."
The FDA adds that if any of the corrective actions taken by West-Ward would result in decreased production, it should contact CDER's Drug Shortages Program immediately.
West-Ward is a subsidiary of London-based Hikma Pharmaceuticals ($HIK). Last year, it expanded its operations with the acquisition of Baxter's multisource injectables business, including a sterile injectable facility. In October, West-Ward CEO Michael Raya said the expansion was in part to take advantage of shortages in the market.
- here's the FDA warning letter
West-Ward sees shortages as 'major opportunity'