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...]
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...]
Teva Pharmaceutical Works Pvt. Ltd. Receives “Microbiologically Loaded” Warning Letter
Teva Pharmaceutical Works Pvt. Ltd. receives "Microbiologically Loaded" Warning Letter (Click Here)Â as a result of a FDA inspection which occurred from January 21 -29, 2016. As a result of this inspection, a Form FDA 483 and a Warning Letter (October 13, 2016) were issued. The Warning Letter consisted of seven citations, many of them dealing with media fills and … [Read more...]
INDIAN MFG FACILITIES RECEIVE WARNING LETTER FOR PROBLEMS ASSOIATED WITH THE ASEPTIC PROCESSING AREA (APA) (102215)
The U.S. Food and Drug Administration (FDA) inspected the following two pharmaceutical manufacturing facilities: August 25-29, 2014: Sandoz Private Limited, MIDC Plot Nos. 8-A/2 & 8-B, TTC Industrial Area, Kalwe Block, Village Dinghe, Navi Mumbai 400 708, Maharashtra, India (Kalwe facility) August 12-28, 2014: Sandoz Private Limited, Plot Nos. D31 & D32, MIDC, TTC … [Read more...]
PHARMACIA UPJOHN FACILITY RECEIVES SECOND FDA FORM 483 IN ALMOST FIVE YEARS
IS A WARNING LETTER FORTHCOMING? A Pharmacia Upjohn subsidiary of Pfizer (Kalamazoo, MI) received a FDA Form 483 following an inspection from June 23 through July 9, 2015. This eight Observation 483 covered both non-sterile and aseptic issues. This audit used the Agency’s recently introduced team-based inspection approach and included Thomas Cosgrove, … [Read more...]
