OHM Pharma of Mineral Wells, Texas drew a warning letter from the FDA for serious violations including inadequate cleaning.
Agency investigators found an unidentified white residue in hallways and rooms in production areas that had been identified as clean.
The facility also used non-dedicated equipment and production areas for manufacturing a variety of drugs and supplements, posing a risk of cross-contamination. It produced some products with potentially toxic ingredients, such as boric acid, and manufactured other drug products intended for children and infants, the agency said.
In addition, the company failed to validate its manufacturing processes and could not produce records to support the production parameters of a drug product meant for teething infants. Batch records also lacked the “specificity required to enable reproducibility” — such as specific information for important manufacturing steps.
The agency also cited the firm for deficient microbiological test methods for water and finished products.