Manufacturing Compliance Updates, In Brief
Executive Summary
FDA warning letter says Foshan Flying Medical Products needs to hire more people in quality control and improve its sterility testing; EU GMP noncompliance notice goes to Bristol Labs in the UK for data integrity flaws; FDA hits six firms with drug GMP import alerts.
Chinese OTC Maker Needs To Beef Up Quality Unit
An inadequately staffed quality unit and incomplete batch records landed Foshan Flying Medical Products Co. of Guangdong, China in hot water with FDA investigators.
The agency’s warning letter said that the firm does not have enough employees in the quality control unit, and that having only a single employee covering the production unit and the quality control assurance unit is not sufficient. The letter was released on Aug. 1 but posted on Aug. 30. The company makes antiseptic wipes and first-aid kits.
The warning letter also states that the firm released finished drug products without adequate acceptance testing, including testing for critical microbial attributes. In addition, the firm failed to ensure the products were sterile, although product labels assert they were.
FDA also took issue with the firm's lack of batch records. The letter states that “during the inspection, our investigator asked to review batch records for your products. Your employee was only able to provide a single recent batch records. … When our investigator asked to see your other batch records, your staff stated that there were no other records.”
Foshan’s senior management said that batch records are only retained for six months after production, yet they are supposed to be kept for at least a year after the drug’s expiration date, FDA said.
FDA recommended that firm hire a consultant to help it meet GMP requirements. The firm was placed on an import alert on May 23, 2017.
UK Maker Dinged On Data Integrity Concerns
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Aug. 25 issued a statement of non-compliance to Bristol Laboratories, a manufacturer of finished drugs, for data integrity lapses. The firm is based in Luton in the UK.
The agency said that “the inspection in July 2017 identified two critical deficiencies relating to the integrity and recording of GMP critical data and with the ongoing stability monitoring program.” The company manufactures generic medicines for the UK and EU markets. The statement of non-compliance was on the EudraGMDP website. The notice covers the firms’ manufacture of non-sterile products including capsules and tablets.
The agency has prohibited the supply of the firm’s “non-critical products” in the EU until the problems are fixed.
Recent Drug GMP Import Alerts
FDA recently added six facilities to its drug GMP import alert, banning imports of drug substances and drug products made at these facilities until they resolve undisclosed manufacturing issues. The companies, locations and dates added are:
- Mahendra Chemicals, Ahmedabad, India, Aug. 25;
- Amaros Co, Ltd, Seongnam, Republic of South Korea, Aug. 23;
- Seindni Co. Ltd, Seoul, Republic of South Korea, Aug. 23;
- Shandong Vianor Biotech Co, Shandong China, Aug. 22;
- Guangdong Zhanjiang Jimin Pharmaceuticals, Guangdong, China, Aug. 21
- Kim Chemicals, Maharashtra, India, Aug. 21
From the editors of The Gold Sheet.