Investigators → David K. Chen
ORA-NE-NJK · Northeast Division (New Jersey District)
Strictness Percentile: 77th
David K. Chen — FDA Investigator Citation Profile
Focuses heavily on 21 CFR 211.100(a) and 21 CFR 211.192. 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 211.100(a), 21 CFR 211.192, 21 CFR 211.160(b)
Simulate Inspection by David K. Chen →
Recent Form 483s Linked to David K. Chen
Right Value Drug Stores LLC (2026-09-08) · 4 observations
View 483 →IntegraDose Compounding Services LLC (2026-08-12) · 4 observations
View 483 →Jubilant HollisterStier LLC (2026-06-17) · 4 observations
View 483 →Emcure Pharmaceuticals Limited (2026-05-15) · 4 observations
View 483 →Turbare Manufacturing (2026-05-07) · 4 observations
View 483 →BioLife Plasma Services, L.P. (2026-04-22) · 4 observations
View 483 →Wells Pharmacy Inc (2026-04-09) · 4 observations
View 483 →Becton Dickinson Infusion Therapy Systems, Inc. (2026-03-26) · 4 observations
View 483 →The Mentholatum Company (2026-03-23) · 4 observations
View 483 →The Harvard Drug Group, LLC dba Major Pharmaceutical and Rugby Laboratories (2026-03-20) · 4 observations
View 483 →Cardinal Health 414, LLC (2026-03-18) · 4 observations
View 483 →Custom Analytics LLC (2026-03-12) · 4 observations
View 483 →Aurorium LLC (2026-03-06) · 4 observations
View 483 →Delta Kozmetik Sanayi Ve Ticaret-Selim Yesil (2026-03-05) · 4 observations
View 483 →Vera Therapeutics, Inc. (2026-03-02) · 4 observations
View 483 →