Aurobido Pharma has been sent a warning letter by the US Food and Drug Administration (FDA). A copy of the letter is yet to be published by the FDA but Aurobindo said it relates its cephalosporin plant.
Earlier this year the FDA banned shipments from the unit. Aurobindo must also give the FDA an action plan for improving packaging and labelling compliance at a Hyderabad, India plant that produces finished dosage forms of non-penicillin and non- cephalosporin drugs.
The FDA has sent a warning letter to Cephazone Pharma after inspecting its facility in Pomona, California, US. Cephazone sent a response to observations made by the agency but it was deemed to lack sufficient corrective actions.
Violations in the warning letter include: a lack of laboratory testing to decide if each batch is sterile; failure to set up written procedures to prevent microbiological contamination of sterile products; and a need for controls over computer systems used for changes in control records.
Golden State Medical Supply (GSMS) has received a warning letter after the FDA inspected its plant in Camarillo, California in February. The visit followed a December 2010 inspection and noted at least one repeat violation.
In the warning letter the FDA cites failure: to launch a full investigation when a batch falls short of its specifications; to have a written testing programme to assess stability characteristics; and to limit access to certain materials to authorised staff.
A warning letter was sent to Ningbo Smart Pharmaceutical following an inspection of its active pharmaceutical ingredient (API) plant in Ningbo, China. During the inspection the FDA noted a number of specific deviations from current good manufacturing practice (cGMP).
Deviations include: failure to have materials properly tested by the quality control unit; insufficient actions to ensure APIs are manufactured in compliance with cGMP; and a lack of at least one identity test for each patch.
“It is essential that your firm only report results to customers when you have actually performed the analysis. This serious cGMP deviation raises concerns regarding the reliability and integrity of other data generated by your firm”, said the FDA.
Moehs Cantabra has received a warning letter after the FDA inspected its API plant in Polanco Cantabria, Spain in December 2010. The FDA warns compliance with cGMP standards is needed if the company is to continue shipping APIs to the US.
Problems detailed in the warning letter include: failure to investigate and document out-of-specification results; a lack of complete and reliable laboratory control records; and shortcomings in product quality reviews.
The FDA has sent a warning letter to Octapharma AB following a January inspection of its plant in Stockholm, Sweden. Deviations from cGMP were noted during production of Octagram and its intermediates.
“There were numerous deviations concerning clarity and IgA in final containers during your validation studies that were not addressed and that continued during manufacture of distributed final container lots”, said the FDA.