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FDA Investigator Citation Signatures & Inspection Prep Briefs

See which 21 CFR clauses each FDA investigator cites most frequently by industry and simulate their audit focus in our AI Mock Inspection.

ORA-SW-DAL 47 Tracked 483s
Marcus V. Delgado
Southwest Division (Dallas District)
Most Frequently Cited 21 CFR Clauses:
21 CFR 111.75(a)(1)(i)21 CFR 111.205(a)21 CFR 117.35(c)

Focuses heavily on 21 CFR 111.75(a)(1)(i) and 21 CFR 111.205(a). 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.

Full Citation Profile → Prep with AI Mock Audit →
ORA-W-LOS 53 Tracked 483s
Elena R. Rostova
Pacific Southwest Division (Los Angeles District)
Most Frequently Cited 21 CFR Clauses:
21 CFR 111.75(a)(2)(ii)21 CFR 111.260(e)FD&C Act Sec. 605 / MoCRA Serious Adverse Event

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.

Full Citation Profile → Prep with AI Mock Audit →
ORA-NE-NJK 61 Tracked 483s
David K. Chen
Northeast Division (New Jersey District)
Most Frequently Cited 21 CFR Clauses:
21 CFR 211.100(a)21 CFR 211.19221 CFR 211.160(b)

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.

Full Citation Profile → Prep with AI Mock Audit →
ORA-C-CHI 42 Tracked 483s
Sarah J. Lindqvist
Central Division (Chicago District)
Most Frequently Cited 21 CFR Clauses:
21 CFR 1.502(a)21 CFR 117.35(c)21 CFR 117.135

Focuses heavily on 21 CFR 1.502(a) and 21 CFR 117.35(c). 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.

Full Citation Profile → Prep with AI Mock Audit →
ORA-FOREIGN-IND 58 Tracked 483s
Priya N. Subramanian
Office of Global Operations (Foreign Drug & API Cadre)
Most Frequently Cited 21 CFR Clauses:
21 CFR 211.67(a)21 CFR 211.19221 CFR 11.10

Focuses heavily on 21 CFR 211.67(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.

Full Citation Profile → Prep with AI Mock Audit →
ORA-SE-FLA 39 Tracked 483s
Thomas W. Halvorsen
Southeast Division (Florida District)
Most Frequently Cited 21 CFR Clauses:
21 CFR 820.100(a)21 CFR 820.198(a)21 CFR 111.75(c)

Focuses heavily on 21 CFR 820.100(a) and 21 CFR 820.198(a). 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.

Full Citation Profile → Prep with AI Mock Audit →
ORA-W-SEA 34 Tracked 483s
Rebecca M. Okafor
Pacific Northwest Division (Seattle District)
Most Frequently Cited 21 CFR Clauses:
21 CFR 117.1021 CFR 1.502(a)21 CFR 820.50

Focuses heavily on 21 CFR 117.10 and 21 CFR 1.502(a). 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.

Full Citation Profile → Prep with AI Mock Audit →
ORA-SW-DEN 45 Tracked 483s
Jonathan A. Vance
Southwest Division (Denver District)
Most Frequently Cited 21 CFR Clauses:
21 CFR 111.75(a)(1)(i)21 CFR 111.75(c)21 CFR 111.553

Focuses heavily on 21 CFR 111.75(a)(1)(i) and 21 CFR 111.75(c). 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.

Full Citation Profile → Prep with AI Mock Audit →