LLOYD, Inc. of Iowa

Form 483 issued September 15, 2023 · Shenandoah, Iowa

Observations: 7
Pages: 5
FEI number: 1911196

In short: On September 15, 2023, FDA issued a Form 483 with 7 observations to LLOYD, Inc. of Iowa in Shenandoah, Iowa (FEI 1911196). Most observations concern facilities & equipment and production.

At a glance

Observations span 4 systems, led by facilities & equipment.

Facilities & equipment3

Production1

Laboratory controls1

Quality system1

Other1

What FDA observed

Preview: the opening words of each observation

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

01
21 CFR 211.58
Buildings used in the holding of a drug product are not maintained in a…
02
21 CFR 211.113
Procedures designed to prevent objectionable microorganisms in drug products not required to be…
03
21 CFR 211.160
Laboratory records do not include complete records of any testing and standardization of laboratory reference…
04
21 CFR 211.22
The responsibilities and procedures applicable to the quality control unit…

3 more observations

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

Get the full 483

This inspection in context

The firm

LLOYD, Inc. of Iowa history

All 3 documents on file for this site, in date order, with what was cited at each inspection.

Similar 483s

Other sites cited under 211.58

See how FDA wrote the same problem up elsewhere.

Questions about this 483

What did FDA find at LLOYD, Inc. of Iowa?

FDA listed 7 observations on this Form 483, mostly about facilities & equipment, production and laboratory controls. The opening words of each observation are shown on this page.

When was LLOYD, Inc. of Iowa inspected by FDA?

This Form 483 is dated September 15, 2023.

How do I get the full Form 483 for LLOYD, Inc. of Iowa?

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.