A really slow week — 1 letter to a compounding pharmacy and 1 to a firm for misbranded unapproved drug marketing. We cover the compounding pharmacy letter consistent with past practices.
COMPOUNDING PHARMACY:
- Gipsco Investment Corp dba Lee Silsby Compounding Pharmacy (Cleveland Heights, OH) received a warning letter on July 10th 2018 based on the outcome of an inspection ending June 9th 2017 (not a typo). The firm fails to meet the considerations in Section 503A of the FD&C Act. The warning letter identifies 4 GMP deficiencies for sterile product manufacturing. In addition, the products are misbranded because labeling is not compliant with requirements.