API issues served as a highlight for one of two Warning Letters issued last week. That one was issued to a drug product manufacturer following a March inspection. The second Warning Letter was sent to a compounding pharmacy.
Drug Warning and Untitled Letters
RLC Labs Inc
RLC Labs Inc (Phoenix, AZ) received a Warning Letter on October 9, 2020, based on the outcome of an inspection ending March 5, 2020. FDA deemed the firm’s products adulterated as the firm failed to register appropriately with the agency. FDA also encouraged the firm to hire a qualified GMP consultant(s) to assist them in coming into compliance with GMPs. Their WP Thyroid and Nature-Thyroid products are also deemed misbranded because they do not conform to published compendial standards. These products are also considered biological products. Deficiencies identified during the inspection include but are not limited to:
- The firm’s Quality Unit did not review and approve written procedures for production and process control. The manufacturing processes have not been validated. Critical equipment was not qualified. Further, of the ten samples collected during the inspection, six of them were sub-potent for at least one or two active ingredients. Of particular concern is the narrow therapeutic range for these drugs.
- No stability data have been generated for the current product with API from the current API supplier.
- There is no specification for API and individual API lots are not tested to ensure they meet specifications prior to being blended into a larger API lot.
- The Quality Unit failed to ensure the firm had adequate procedures and did not provide adequate oversight of manufacturing activities. Further, the Quality Unit was not aware of complaint spreadsheets being maintained outside the Quality Unit, and, therefore, these complaints were not investigated by the Quality Unit.
Device Warning and Untitled Letters
There were none this week.
BIMO, GCP and GLP Warning and Untitled Letters
There were none this week.
Compounding Pharmacy/Outsourcing Facilities
Medoz Pharmacy of Polk Inc (Davenport, FL) received a Warning Letter on September 25, 2020, based on an inspection conducted on August 9, 2019. The firm has ceased sterile compounding and given up their Florida Department of Health Sterile compounding permit.
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