FDA 483 - MasterPharm LLC - June 15, 2020

This FDA Form 483, issued to MasterPharm LLC, a producer of sterile and non-sterile drug products located at 115-02 Liberty Avenue, South Richmond Hill, NY, details observations from an inspection conducted on May 28-29, June 1, 8, and 15, 2020. The inspection identified several significant violations.

Observation 1 notes that the firm released approximately (b)(4) Tadalafil 7 mg Capsules, Lot #01-22-2020, with a confirmed out-of-specification (OOS) potency of 80.4% (specification 1(b)(4)%), which were dispensed and remained on the market.

Observation 2 highlights difficult-to-clean, particle-generating, and visibly dirty equipment and surfaces in ISO-classified aseptic processing areas. Specifically, dark marks were observed on the material (b)(4) separating ISO 5 and ISO 7 areas, used for transferring materials for sterile products, without a cleaning regimen. Hard-to-reach (b)(4) areas within the ISO 5 Cleanroom (b)(4) were also not cleaned.

Observation 3 details non-microbial contamination, including rust-like material on a sanitizer dispenser in the ISO 7 anteroom and visible white product residue and chipped metallic coating on a flammable container in the ISO 7 hazardous non-sterile