FDA Intel

Winco Mfg., LLC

Form 483 issued July 12, 2018 · Ocala, Florida

Inspection
Jul 9 – Jul 12, 2018
Investigator
Richard K. Vogel
Observations
6
Pages
6
FEI number
1027229

In short: On July 12, 2018, FDA issued a Form 483 with 6 observations to Winco Mfg., LLC in Ocala, Florida (FEI 1027229) after an inspection that ran Jul 9 – Jul 12, 2018. The investigator was Richard K. Vogel. Most observations concern cAPA and production & process controls.

At a glance

4 of 6 observations on this 483 concern capa.

CAPA4
Production & process controls2

What FDA observed

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

    Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements…

  2. 02
    21 CFR 820.100(a)

    Procedures for corrective and preventive action have…

  3. 03
    21 CFR 803.50(a)(1)

    An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of…

  4. 04
    21 CFR 803.17(a)(3)

    The written MDR procedure does not include an internal system which provides for timely transmission of…

2 more observations

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

Get the full 483

This inspection in context

The investigator

Richard K. Vogel

4 documents · 2010–2018

Cites 820.30 (design controls) more than any other section. Most of their documents are for sites in Florida.

The firm

Winco Mfg., LLC history

The site's inspection history, in date order.

Similar 483s

Other sites cited under 820.50

See how FDA wrote the same problem up elsewhere.

Questions about this 483

What did FDA find at Winco Mfg., LLC?

FDA listed 6 observations on this Form 483, mostly about cAPA and production & process controls. The opening words of each observation are shown on this page.

Who inspected Winco Mfg., LLC?

Richard K. Vogel is named on this Form 483, for the inspection of Jul 9 – Jul 12, 2018. Each investigator has a profile showing what they cite most.

When was Winco Mfg., LLC inspected by FDA?

The inspection ran Jul 9 – Jul 12, 2018, and the Form 483 is dated July 12, 2018.

How do I get the full Form 483 for Winco Mfg., LLC?

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