American Welding & Gas, Inc.

Form 483 issued July 11, 2019 · Columbia, South Carolina

Investigator
Lillie D. Witcher
Observations
1
Pages
2
FEI number
3012103599

In short: On July 11, 2019, FDA issued a Form 483 with 1 observation to American Welding & Gas, Inc. in Columbia, South Carolina (FEI 3012103599). The investigator was Lillie D. Witcher. Most observations concern production; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).

At a glance

1 of 1 observations on this 483 concern production.

Production1

Most cited: 21 CFR 211.100(a) (1×)

What FDA observed

Preview: the opening words of each observation
  1. 01

    Written procedures are not drafted, reviewed and approved by…

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 American Welding & Gas, Inc.?

FDA listed 1 observation on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.

Who inspected American Welding & Gas, Inc.?

Lillie D. Witcher is named on this Form 483. Each investigator has a profile showing what they cite most.

When was American Welding & Gas, Inc. inspected by FDA?

This Form 483 is dated July 11, 2019.

How do I get the full Form 483 for American Welding & Gas, Inc.?

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