A maker of over-the-counter products that include medicines for infants and children has been told by the FDA that it must completely remake its water system because it failed to prevent high levels of bacteria in its products.
The FDA demand came in a warning letter issued to Middletown, New York-based RIJ Pharmaceutical after an inspection in March found unacceptable levels of three bacteria in the water including "at points of use."
On top of that, the drugmaker was chastised because it had not conducted process validation studies for its mixing processes, which resulted in it making super-potent batches of acetaminophen elixir and pseudoephedrine liquid.
“Your firm manufactures products such as a pediatric acetaminophen elixir that can cause serious adverse effects if significantly super-potent,” the warning letter pointed out.
The FDA said RIJ did not adequately investigate customer complaints about odors in RIJ sennosides laxative syrup and was not maintaining all the necessary data from testing.
The FDA was not satisfied with the company’s pledges to improve its systems and ordered it to provide further responses as to how that will happen.
The FDA has little patience with companies when products for children are involved. Last year, it slapped a warning letter on New Jersey-based Tris Pharma, citing its lack of urgency about investigating product failures. The company later recalled three lots of an infants' pain reliever it says contained potentially high levels of ibuprofen that could cause permanent kidney damage in some children. The recall included products sold to Walmart, CVS and Family Dollar stores.