FDA Intel

Patrin Pharma, Inc

Form 483 issued May 6, 2019 · Niles, Illinois

Inspection
May 2 – May 6, 2019
Investigator
Emma R. Schaefer
Observations
5
Pages
4
FEI number
3006557630

In short: On May 6, 2019, FDA issued a Form 483 with 5 observations to Patrin Pharma, Inc in Niles, Illinois (FEI 3006557630) after an inspection that ran May 2 – May 6, 2019. The investigator was Emma R. Schaefer. Most observations concern cAPA and production & process controls.

At a glance

CAPA and production & process controls account for 3 of 5 observations.

CAPA2
Production & process controls1
Management controls1
Records & documents1

What FDA observed

Preview: the opening words of each observation
  1. 01
    21 CFR 820.50(a)

    Requirements that must be met by suppliers and contractors…

  2. 02
    21 CFR 820.198(a)

    Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have…

  3. 03
    21 CFR 820.100(a)

    Procedures for corrective and preventive action…

  4. 04
    21 CFR 820.22

    Procedures for quality audits have…

1 more observation

Plus the full detail behind each one, exactly as FDA wrote it.

Get the full 483

This inspection in context

The investigator

Emma R. Schaefer

4 documents · 2018–2021

Cites 820.50 (purchasing controls) more than any other section. Most of their documents are for sites in Illinois.

The firm

Patrin Pharma, Inc history

All 2 documents on file for this site, in date order, with what was cited at each inspection.

Similar 483s

Other sites cited under 820.50(a)

See how FDA wrote the same problem up elsewhere.

Questions about this 483

What did FDA find at Patrin Pharma, Inc?

FDA listed 5 observations on this Form 483, mostly about cAPA, production & process controls and management controls. The opening words of each observation are shown on this page.

Who inspected Patrin Pharma, Inc?

Emma R. Schaefer is named on this Form 483, for the inspection of May 2 – May 6, 2019. Each investigator has a profile showing what they cite most.

When was Patrin Pharma, Inc inspected by FDA?

The inspection ran May 2 – May 6, 2019, and the Form 483 is dated May 6, 2019.

How do I get the full Form 483 for Patrin Pharma, Inc?

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