OTC drugmaker AmeriDerm Laboratories has a long history of failing to test its Paterson, N.J., plant’s water supply for objectionable microorganisms, the FDA says.
The company has not tested its water supply for potentially hazardous bugs since 2006, a warning letter published by the agency Dec. 10 states. During a February inspection of the plant, investigators tested AmeriDerm’s water and found four objectionable microorganisms.
In response, the drugmaker promised to sample water supplies multiple times a year. However, the FDA said that alone won’t suffice as AmeriDerm uses deionized water, not purified water as required under current good manufacturing practices. The company also failed to determine the root cause of the contamination, according to the letter.
Noting that some of AmeriDerm’s products are designed for use in nursing homes or for topical application on broken skin, the agency said it is “critical that [AmeriDerm] considers the intended uses of your products when determining manufacturing and testing standards.” The FDA urged the drugmaker to consult agency guidance on high-purity water system design and inspections.
Investigators also highlighted a number of validation shortfalls at the Paterson plant. AmeriDerm has not validated the manufacturing processes for four of its products, including a wound care product and an incontinent care product, the warning letter states. Component attributes such as product solubility and viscosity have not been identified for each drug product, nor have process parameters such as mixing time and blending speed been established, according to the agency.
Significant process steps are not always documented in company batch records, the FDA added.
The drugmaker was also chided for lacking robust procedures for cleaning and sanitization of non-dedicated manufacturing equipment. And AmeriDerm lacked individual equipment logs to document cleaning activities, the letter states.
“AmeriDerm has addressed all of the issues raised in the warning letter with the FDA and is in close contact with the agency,” President Bernie Elefant said.
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