Brazil’s Lima & Pergher was hit with an FDA warning letter in the wake of a February inspection that found significant violations at the company’s manufacturing facility.
The regulatory agency’s warning letter, issued Aug. 25, cited poor quality control that resulted in adulterated drugs coming out of the plant located in Uberlandia within the state of Minas Gerais in Brazil.
Specifically, the agency said the drugmaker failed to perform microbiological testing on each lot of finished product and had no stability data to support expiration dates on its drugs.
Additionally, inspectors noted that the facility’s raw material qualification process was inadequate for its drug products.
The FDA also recommended that Lima & Pergher hire a qualified consultant to get their factory in order.
The agency placed the company on its import alert list in July, effectively banning the company from distributing its drugs in the U.S.
- check out the warning letter