FDA Inspection
Judith Guzman-Cottrill, D.O.Judith Guzman-Cottrill, D.O. – FDA Inspection, Oct 11, 2012
Record Details
This FDA Inspection record concerns Judith Guzman-Cottrill, D.O., with an inspection on October 11, 2012, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Judith Guzman-Cottrill, D.O.
- Inspection Date
- October 11, 2012
- Product Type
- Biologics
View Company Profile
ID · 74194d1a-63d8-4a02-b248-92080a7d93dc
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 805939
- FDA center
- Biologics
- Project area
- Bioresearch Monitoring
FDA Citations
8- 21 CFR 312.60FD-1572, protocol compliance
- 21 CFR 312.68FDA access to clinical investigator records
- 21 CFR 312.62(b)Case history records- inadequate or inadequate
- 21 CFR 312.66Unanticipated problems
- 21 CFR 50.27(a)Consent form not approved/signed/dated
- 21 CFR 312.62(a)Accountability records
- 21 CFR 50.25(b)(1)Statement of risks
- 21 CFR 50.25(a)(2)Reasonably foreseeable risks or discomforts
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