Burkmann Feeds of Glasgow LLC

Form 483 issued February 22, 2017 · Glasgow, Kentucky

Inspection
Dec 21, 2016 – Feb 22, 2017
Observations
4
Pages
4
FEI number
3003314519

In short: On February 22, 2017, FDA issued a Form 483 with 4 observations to Burkmann Feeds of Glasgow LLC in Glasgow, Kentucky (FEI 3003314519) after an inspection that ran Dec 21, 2016 – Feb 22, 2017. The investigator was Christian L. Witkovskie. The most-cited regulation is 21 CFR 225.65 (equipment cleanout procedures).

What FDA observed

Preview: the opening words of each observation

Dashed: section inferred by FDA Intel and checked against the regulation text

  1. 01
    21 CFR 225.30

    Equipment for producing medicated feeds of intended potency and purity is not designed, constructed, installed and…

  2. 02
    21 CFR 225.65

    Adequate procedures are not for all equipment used in the production and distribution of medicated feeds…

  3. 03
    21 CFR 225.42

    Adequate procedures are not established for the storage and inventory control (receipt and use) of all…

  4. 04
    21 CFR 225.42

    The packaged Type B medicated feed are not stored in…

The full 483

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

Get the full 483

This inspection in context

Questions about this 483

What did FDA find at Burkmann Feeds of Glasgow LLC?

FDA listed 4 observations on this Form 483. The most-cited regulation is 21 CFR 225.65 (equipment cleanout procedures). The opening words of each observation are shown on this page.

Who inspected Burkmann Feeds of Glasgow LLC?

Christian L. Witkovskie is named on this Form 483, for the inspection of Dec 21, 2016 – Feb 22, 2017. Each investigator has a profile showing what they cite most.

When was Burkmann Feeds of Glasgow LLC inspected by FDA?

The inspection ran Dec 21, 2016 – Feb 22, 2017, and the Form 483 is dated February 22, 2017.

How do I get the full Form 483 for Burkmann Feeds of Glasgow LLC?

Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.

$99Get it free