Investigators → Elena R. Rostova
ORA-W-LOS · Pacific Southwest Division (Los Angeles District)
Strictness Percentile: 72th
Elena R. Rostova — FDA Investigator Citation Profile
Focuses heavily on 21 CFR 111.75(a)(2)(ii) and 21 CFR 111.260(e). Expect a request for your Approved Supplier List, raw component identity testing chromatograms, and last 24 months of OOS/CAPA logs within the first 2 hours of opening conference.
Top Cited Clauses: 21 CFR 111.75(a)(2)(ii), 21 CFR 111.260(e), FD&C Act Sec. 605 / MoCRA Serious Adverse Event
Simulate Inspection by Elena R. Rostova →
Recent Form 483s Linked to Elena R. Rostova
Greenwich Rx (2026-09-09) · 3 observations
View 483 →Carolina Infusion LLC (2026-08-18) · 3 observations
View 483 →XeCare LLC (2026-06-17) · 3 observations
View 483 →Lonza Bend Inc. (2026-05-19) · 3 observations
View 483 →Perrigo New York, Inc. (2026-05-08) · 3 observations
View 483 →Jiangsu Hansoh Pharmaceutical Group Co Ltd. (2026-04-24) · 3 observations
View 483 →Wells Pharma of Houston LLC (2026-04-13) · 3 observations
View 483 →Revive Rx LLC (2026-03-27) · 3 observations
View 483 →Catalent CTS, LLC (2026-03-23) · 3 observations
View 483 →Abbisko Therapeutics Co., Ltd. (2026-03-20) · 3 observations
View 483 →Veterinary Pharmacy Corporation (2026-03-19) · 3 observations
View 483 →BayCare Integrated Service Center LLC (2026-03-12) · 3 observations
View 483 →IsoTis OrthoBiologics, Inc. (2026-03-06) · 3 observations
View 483 →Accura-Pac, Inc. (2026-03-05) · 3 observations
View 483 →KEDPLASMA LLC (2026-03-03) · 3 observations
View 483 →