FDA 483 - Flamma SpA - September 21, 2018

SICOR Societa Italiana Corticosteroidi s.r.l. in Bulciago, Italy, was inspected and cited for significant deficiencies across its manufacturing and quality control operations. Observations included inadequate warehousing of critical materials, ineffective root cause investigations for out-of-specification results, and failures in CAPA implementation. Additionally, the firm demonstrated poor protection of APIs from contamination, insufficient equipment cleaning during campaign production, and a lack of verification for analytical instruments and scales before use.