Institute of Good Manufacturing Practices India
Global accredited training & certification provider
Approved by Quality Council Of India (QCI), Government of India
An ISO 9001:2008 Certified Organisation
Registered under The Societies Registration Act,1860 Government of India
Empanelled under Ministry of Horticulture and Food Processing, Government of Uttar Pradesh
International Register of Certificated Auditors (IRCA) accredited Lead Auditor (FSMS) course
Affiliated with Life Sciences Sector Skills Council (SSC) and Food Industry Sector Skills Council set up by National Skill Development Corporation (NSDC)
New Delhi | Noida | Hyderabad | Lucknow

Trusted by organizations & training participants in over 25 countries
Training | Certification | Education | Research

Warning given to Japanese active pharmaceutical ingredient (API) maker Nippon Fine Chemical Co., Ltd for impeding an FDA inspection

The US Food and Drug Administration (FDA) has warned Japanese active pharmaceutical ingredient (API) maker Nippon Fine Chemical Co., Ltd for impeding an FDA investigator from conducting an inspection of the company's facility in Takasago City, Japan, last December.

According to FDA, Nippon Fine Chemical employees physically blocked an FDA investigator from conducting portions of the inspection, refused to hand over records and prevented FDA from taking photographs of equipment at the facility. A quality control manager for the company told employees to "stand shoulder-to-shoulder”, barring the investigator from accessing portions of the laboratory and the equipment used to analyze drugs for U.S. distribution. The quality assurance manager also prevented the investigator from taking photographs of certain equipment used to make drugs destined for the US.

According to FDA, shipments from the company's Takasago City facility will continue to be refused until FDA is able to re-inspect the facility and ensure it is in compliance with current good manufacturing practice (cGMP). FDA says it considers the company's products to be adulterated under CFR 21 Section 351(j), which states that a drug or device is considered to be adulterated if "it has been manufactured, processed, packed, or held in any factory, warehouse, or establishment and the owner, operator, or agent of such factory, warehouse, or establishment delays, denies, or limits an inspection, or refuses to permit entry or inspection.”



Contact Us