OR WAIT null SECS
The agency sent a warning letter to Opto-Pharm Pte Ltd. after deficiencies in sterile manufacturing procedures were found at the company’s Singapore facility.
FDA sent a warning letter to Opto-Pharm Pte Ltd., dated March 16, 2017, regarding current good manufacturing practice (CGMP) violations found at the company’s Singapore facility in March 2016. FDA investigators found deficiencies in the company’s sterile manufacturing, stability testing, and validation procedures.
The agency stated in the warning letter that appropriate written procedures were not established or followed for the prevention of microbiological contamination in sterile products. The company received customer complaints of leaking containers. FDA inspectors noted that after the company had observed the leaking containers it adjusted equipment, resumed production, and released the lots. The company also failed to properly address container-closure defects. “Container integrity is imperative to ensure sterility of ophthalmic drug products. The lack of assurance that your (b)(4) equipment consistently manufactures an integral container-closure system diminishes confidence in the sterility of your marketed products,” the agency stated in the letter.
Other sterile manufacturing issues involved the reuse of single-use manufacturing components and a failure to validate processes. “It is essential that your firm improves your process design and control to correct the root causes of your recurring container-closure integrity defects. Without such remediation, successful process performance qualification studies alone are insufficient to demonstrate that your process is truly capable of a continuing state of control,” FDA stated.
The company also failed to conduct appropriate stability testing for some products, according to FDA. Raw data for other stability studies were not provided to the agency; therefore, expiration dates of products might not be accurate. “Your failure to conduct stability studies and lack of data supporting expiration dates compromises your ability to detect quality problems with marketed ophthalmic products. Without stability data, you cannot assure the quality of your products throughout their labeled shelf lives,” the agency stated.
FDA is asking the company to provide raw stability data for all ophthalmic products manufactured for the US market; antimicrobial effectiveness testing to evaluate the preservation of products; and an evaluation of its preservation systems. The agency also recommended the company obtain a CGMP consultant.