California OTC Firm Hit for Complaint Investigations, Data Integrity
Sunrider Manufacturing of Torrance, California drew a Form 483 from the FDA for incomplete complaint investigations and data integrity violations at its OTC manufacturing facility.
An agency inspection revealed that the firm failed to fully investigate customer complaints. For example, the agency investigators reviewed five complaint reports of skin reactions for a sunscreen product and found incomplete investigations for four of the complaints. Similarly, eight complaint reports for a moisture lotion were noted as incomplete.
The complaints lacked information that should have been gathered through quality unit investigations under the facility’s standard operating procedure, the agency said.
The investigators also observed data integrity violations. The firm failed to ensure electronic data security in software and operating systems, lacked audit trails during analytical software validations and didn’t contemporaneously document data.