USFDA issues warning letters for GMP violations

There has been a general increase in warning letters issued by USFDA, for violations of good manufacturing practice (GMP) standards. Recently, USFDA conducted inspections at some food and drug manufacturing sites and issued warning letters to the companies.

One warning letter was issued to Gadre Marine Export Pvt. Ltd. after inspection of the seafood processing facility located at Chorwad, Gujarat, India last year. During this inspection it was found that there were violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR 123). This resulted in a Form 483 listing the inspection observations.

Another warning letter was issued to Avella of Deer Valley, Inc. in Phoenix. The inspection was conducted last year and the inspectors observed that valid prescriptions were not being received from patients for the drug products being produced. Also, there were serious deficiencies in practices regarding production of sterile drug products like performing aseptic operations wearing non-sterile gowns and with skin exposed. These and others observations were noted in Form 483.

Yet another warning letter was issued to Oskri Corporation, after USFDA inspected their snack food manufacturing facility located at Lake Mills, Wisconsin. Serious violations of the Current Good Manufacturing Practice (CGMP) regulations in manufacturing, packing, or holding human food were noted during this inspection. This causes the food products to be adulterated and that they are being manufactured, packed and stored in insanitary conditions and can be injurious to health.