OTC drugmaker Emilia Resources drew a Form 483 from the FDA for failing to validate manufacturing processes and establish data controls, among other lapses at its facility in De Kalb, Mississippi.
The agency investigator noted the facility failed to validate manufacturing processes for four of its products to ensure they consistently met quality standards: two sunscreen lotions, a diaper cream and a diaper rash ointment.
The company lacked controls on its computer systems to prevent data from being modified without permission or accountability. Specifically, it didn’t establish controls on laboratory balances and computers to keep the time, time zone and date from being changed.
The laboratory did not always investigate when raw materials, bulk drug products and finished drug products didn’t meet specifications. Additionally, the firm’s quality investigation SOPs lacked guidance on repeated testing for failing results, the agency said.