Mangiacotti, Inc. – FDA Inspection, Dec 19, 2016

Record Details

This FDA Inspection record concerns Mangiacotti, Inc., with an inspection on December 19, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.

Company: Mangiacotti, Inc.
Inspection Date: December 19, 2016
Product Type: Drugs
Office: Center for Drug Evaluation and Research
Person: Jonathan G. Matrisciano (FDA Associated Person)

View Company Profile

ID · 349141fe-75fc-483a-9729-f550d96a1c10

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number: 997947
FDA center: Human Drugs
Project area: Drug Quality Assurance
Outcome: Form 483 issued

FDA Citations

21 CFR 211.25(a)Training--operations, GMPs, written procedures
21 CFR 211.198(a)Complaint Handling Procedure
21 CFR 211.22(d)Procedures not in writing, fully followed
21 CFR 211.150Written distribution procedure

Full citation text and observation details available on the Dashboard.

Discuss this record with AI

KeyPedia

ChatGPT

Claude

Perplexity

Grok

Copilot

Document or profile

One record shows the event. A profile shows the pattern.

Buy this document for the source file and details behind this single event.

Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.

Explore Mangiacotti, Inc.

FDA Inspection

Mangiacotti, Inc.December 19, 2016