FDA Intel

Q A Laboratories Inc

Form 483 issued April 19, 2018 · Kansas City, Missouri

Inspection
Mar 22 – Apr 19, 2018
Investigators
Carl A. Huffman· Kristi B. Panzer· Naseem S. Jouhari
Observations
12
Pages
19
FEI number
1929758

In short: On April 19, 2018, FDA issued a Form 483 with 12 observations to Q A Laboratories Inc in Kansas City, Missouri (FEI 1929758) after an inspection that ran Mar 22 – Apr 19, 2018. The investigators were Carl A. Huffman, Kristi B. Panzer, Naseem S. Jouhari, Veronica Fuentes and Wayne D. McGrath. Most observations concern facilities & equipment and packaging & labeling; the most-cited regulation is 21 CFR 211.192 (production record review).

At a glance

Observations span 4 systems, led by facilities & equipment.

Facilities & equipment3
Packaging & labeling2
Quality system2
Production2
Other3

Most cited: 21 CFR 211.192 (2×)

What FDA observed

Preview: the opening words of each observation
  1. 01
    21 CFR 211.56(a)

    Buildings used in the manufacture, processing, packing or holding of ding products are not maintained in…

  2. 02
    21 CFR 211.58

    Buildings used in the manufacturing, processing, packing and holding of a drug product are not maintained…

  3. 03
    21 CFR 211.80(b)

    There was a faihue to handle and store components and ding product containers at all times…

  4. 04
    21 CFR 211.67(a)

    Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination that would…

8 more observations

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

Get the full 483

This inspection in context

The investigator

Carl A. Huffman

11 documents · 2015–2026

Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Kansas.

The firm

Q A Laboratories Inc history

The site's inspection history, in date order.

Similar 483s

Other sites cited under 211.192

See how FDA wrote the same problem up elsewhere.

Questions about this 483

What did FDA find at Q A Laboratories Inc?

FDA listed 12 observations on this Form 483, mostly about facilities & equipment, packaging & labeling and quality system. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.

Who inspected Q A Laboratories Inc?

Carl A. Huffman, Kristi B. Panzer, Naseem S. Jouhari, Veronica Fuentes and Wayne D. McGrath are named on this Form 483, for the inspection of Mar 22 – Apr 19, 2018. Each investigator has a profile showing what they cite most.

When was Q A Laboratories Inc inspected by FDA?

The inspection ran Mar 22 – Apr 19, 2018, and the Form 483 is dated April 19, 2018.

How do I get the full Form 483 for Q A Laboratories Inc?

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