FDA 483 - D.R. Pharmacy, Inc. - March 06, 2015

The FDA Form 483 inspection revealed several deficiencies in the facility's operations. A primary concern is the absence of potency testing for finished drug products, including BI-EST, TRI-EST Cream, and Opium Tincture Synthetic, Deodorized, prior to release, indicating a lack of appropriate laboratory determination for identity and strength of active ingredients.

The firm also lacks a written testing program for assessing drug product stability, failing to provide data to substantiate Beyond Use Dates (BUDs) of up to 180 days for products like BI-EST and TRI-EST Cream. Control procedures are not established to validate manufacturing processes, and data is not provided to justify the use of a redacted test for homogeneity in suspensions or creams.

Furthermore, specifications for particle size are not established, and testing is not conducted, despite the use of commercially available redacted to reduce particle size in products like Progesterone Suppositories and Tablets. The firm adds redacted preservative to commercially obtained redacted, but no data substantiates its 6-month BUD.

Batch production and control records are deficient, lacking documentation of significant processing steps, specifically pharmaceutical calculations. Approved components are not retested or reexamined after long-term storage; expired Active Pharmaceutical Ingredients (APIs) were observed, and drug products were produced with BUDs extending past component expiration dates.