West-Ward has more than 20 drugs on the US Food and Drug Administration (FDA) shortages list and must now contend with a warning letter at its Eatontown, New Jersey manufacturing plant. Fixing the problems could affect supply and the FDA wants as much warning as possible of any delays.
“If…you are considering a decision that will result in a decreased [output at] your manufacturing facility, FDA requests that you contact [the] drug shortages programme immediately, as you begin your internal discussions”, the Agency wrote in a warning letter sent to West-Ward this month.
The letter refers to two products, lithium carbonate extended release 450mg tablets and digoxin 0.125mg tablets, neither of which are on the shortage list. Most of the West-Ward drugs on the list are generic injectables it bought from Baxter last year along with the Cherry Hill, New Jersey plant.
Problems raised by the FDA are limited to the Eatontown production facility. Some of the failings found by FDA inspectors in June were also identified by the Agency during a visit in February 2010.
Some of the longstanding problems relate to the thickness, hardness, and weight of tablets. During the 2010 inspection the testing tablet systems (TTS) were giving incorrect weights for digoxin tablets when run at the default speed.
“Your firm failed to make a further assessment of the overall reliability of the TTS machines, including evaluating their accuracy with other products and other tablet weights at other speeds”, the FDA wrote.
Inadequate process controls added to hardness and thickness inconsistencies. Inspectors criticised standard operating procedures that allow drug product batches to be released with significant in-process quality defects.
“This could result in the release of a batch that had up to 25 per cent of the units being out of specification without a follow-up investigation to determine the root cause of the high rate of process failures”, the FDA wrote.
Inspectors also said West-Ward failed to document the number of tablets that were rejected when it ran digoxin through a thickness sorter. Accuracy is particularly important when manufacturing digoxin, a treatment for congestive heart failure.
“Digoxin tablets have a narrow therapeutic range and over or underweight tablets can have a significant effect on the patient's health”, the FDA wrote.