Contacare Ophthalmics & Diagnostics – FDA Warning Letter, Nov 1, 2018

The FDA issued a Warning Letter to Contacare Ophthalmics & Diagnostics following an inspection from October 25 to November 1, 2018, citing significant violations of CGMP regulations for finished pharmaceuticals (21 CFR parts 210 and 211). The firm's drug products are deemed adulterated under 21 U.S.C. 351(a)(2)(B). Additionally, the firm introduced unapproved new drugs (Bio-Glo and Green-Glo ophthalmic strips) into interstate commerce, violating 21 U.S.C. 355(a) and 331(d), and these products are misbranded under 21 U.S.C. 352(f)(1).

Key violations include: 1. **Aseptic Processing Area Deficiencies (21 CFR 211.42(c)(10)):** Substantial gaps in the barrier separating ISO 5 and ISO 7 areas, insufficient smoke studies, excessive personnel, poor line design, and improper aseptic technique in the aseptic filling room. The firm's response failed to adequately address these issues or commit to a retrospective risk assessment. 2. **Inadequate Procedures for Sterile Products (21 CFR 211.113(b)):** Media fills failed to simulate manual interventions, and the firm did not commit to additional media fills