The U.S. Food and Drug Administration (FDA) inspected Daito Kasei Kogyo Co., LTD. from July 18 to 21, 2017. They subsequently were placed on an Import Alert 66-40 on October 25, 2017 and received a Warning Letter on January 19, 2018. During the inspection, the investigator observed specific deviations including, but not limited to, the following. Failure to … [Read more...]
Celltrion Inc, Republic of Korea, Receives Warning Letter for Microbiological/Environmental Issues
The U.S. Food and Drug Administration (FDA) inspected Celltrion Inc, Republic of Korea from May 22 – June 2, 2017. On January 26, 2018 the FDA issued a Warning Letter for microbiological/environmental issues that summarizes significant violations of cGMP for finished pharmaceuticals (see 21 CFR, parts 210/211). Several … [Read more...]
Burkholderia cepacia Contamination Creates Recall Situation (08082017)
FDA advises health care professionals and patients not to use any liquid drug products manufactured by PharmaTech and distributed by Rugby Laboratories and possibly other companies CDC lab testing detects product contamination, links products to patient infections [8/8/2017]Â FDA is advising health care professionals and patients not to use any liquid product … [Read more...]
Hospira Issues a Voluntary Nationwide Recall For Multiple Injectable Lots For Potential Lack Of Sterility Assurance (06/15/17)
Hospira, Inc., a Pfizer company, is voluntarily recalling 42 lots of 8.4% Sodium Bicarbonate Injection, USP, 50 mL vials, 5 lots of NeutTM (Sodium Bicarbonate 4% additive solution) 5 mL vials, 5 lots of QUELICINTM (Succinylcholine Chloride Injection, USP) 200 mg/10 mL vials and 7 lots of Potassium Phosphates Injection, USP, 45 mM vials to the hospital/retail level due to … [Read more...]
YUSEF MANUFACTURING RECEIVES WARNING LETTER FOR FAILURE TO MEET APPROPRIATE LABORATORY DETERMINATIONS
Yusef Manufacturing, Clearfield, UT was audited by the FDA from May 23 – 26, 2016. Subsequent to the audit the firm received a total of five citations relating to 21 CFR 211.22(d) (1)(2); 84(d) (1), (2); 100 (a); 192; 165(a), (b). Because of an on-going history of a failure to correct similar citations, the FDA issued the enclosed Warning Letter. In … [Read more...]
