FDA Publishes Five Form 483 Inspection Records
FDA posted five Form 483 inspection records involving three manufacturers, including Dr. Reddy's Laboratories in India and Qingdao Kangyuan Pharmaceutical in China, according to the agency's Office of Inspections and Investigations FOIA Electronic Reading Room.
The newly published records include a June 25, 2026, inspection of Dr. Reddy's, a drug product manufacturer, and three inspection records involving Qingdao Kangyuan, an active pharmaceutical ingredient (API) manufacturer — the Qingdao records date to 2013, 2016 and 2024.
Their availability is part of the agency’s expanded transparency initiative (see earlier story), but a significant limitation in the agency's online FOIA Electronic Reading Room makes it difficult for users to identify newly posted documents: the database does not allow records to be sorted by publication date.
|
Company |
Inspection date |
Location |
FDA Form 483 |
|
Dr. Reddy's Laboratories Ltd. |
June 25, 2026 |
India |
|
|
Analytical Control Systems, Inc. |
March 30, 2026 |
Indiana |
|
|
Qingdao Kangyuan Pharmaceutical Co., Ltd. |
Aug. 16, 2024 |
China |
|
|
Qingdao Kangyuan Pharmaceutical Co., Ltd. |
April 22, 2016 |
China |
|
|
Qingdao Kangyuan Pharmaceutical Co., Ltd. |
Jan. 25, 2013 |
China |