A missive from the Center for Drug Evaluation and Research to the president of Bingbing Pharmaceutical Co., Ltd (emphasis mine):
1. Your firm failed to maintain written production, control, or distribution records specifically associated with a batch of a drug product for at least one year after the expiration date of the batch (21 CFR 211.180(a)).
You manufactured drugs at your Wuhan facility at Building [redacted], No. 5, Kangda Street, Longyang Avenue, Hanyang District, Wuhan, and then transferred drug production to your Hubei facility and closed the Wuhan facility. Your firm failed to maintain manufacturing records, raw material and finished product testing records, retain samples, stability samples, and other CGMP records for your over-the-counter (OTC) [redacted] drug products manufactured at your Wuhan facility. During the inspection at the Hubei facility, you stated that you lost CGMP manufacturing documentation and drug product samples during the transfer of your manufacturing facility from Wuhan to Hubei in May 2018.Yep, happens all the time in moves. You put your batch records in the box, the box gets loaded onto a truck, stuff gets moved around, it gets lost!
I wonder what are the consequences?
ReplyDeleteI recently read Bottle of Lies (Katherine Eban) and was reminded of the disparity between penalties and financial gain related to incompetent, unethical, or outright fraudulent behavior.