FDA Intel

Actavis Laboratories UT, Inc.

Form 483 issued March 19, 2024 · Salt Lake City, Utah

Inspection
Mar 13 – Mar 19, 2024
Investigators
Joan M. Cantellops Figueroa· Santos E. Camara
Observations
5
Pages
8
FEI number
1000117147

In short: On March 19, 2024, FDA issued a Form 483 with 5 observations to Actavis Laboratories UT, Inc. in Salt Lake City, Utah (FEI 1000117147) after an inspection that ran Mar 13 – Mar 19, 2024. The investigators were Joan M. Cantellops Figueroa and Santos E. Camara. Most observations concern facilities & equipment and production.

At a glance

3 of 5 observations on this 483 concern facilities & equipment.

Facilities & equipment3
Production1
Quality system1

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 drug products are not maintained. in…

  2. 02
    21 CFR 211.42(c)(10)(iv)

    Aseptic processing areas are deficient regarding the system…

  3. 03
    21 CFR 211.67(b)

    Written procedures for cleaning and maintenance fail to include maintenance and cleaning schedules and instructions for…

  4. 04
    21 CFR 211.113(a)

    Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not…

1 more observation

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

Get the full 483

This inspection in context

The investigator

Joan M. Cantellops Figueroa

3 documents · 2023–2026

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

The firm

Actavis Laboratories UT, Inc. history

All 2 documents on file for this site, in date order, with what was cited at each inspection.

Similar 483s

Other sites cited under 211.56(a)

See how FDA wrote the same problem up elsewhere.

Questions about this 483

What did FDA find at Actavis Laboratories UT, Inc.?

FDA listed 5 observations on this Form 483, mostly about facilities & equipment, production and quality system. The opening words of each observation are shown on this page.

Who inspected Actavis Laboratories UT, Inc.?

Joan M. Cantellops Figueroa and Santos E. Camara are named on this Form 483, for the inspection of Mar 13 – Mar 19, 2024. Each investigator has a profile showing what they cite most.

When was Actavis Laboratories UT, Inc. inspected by FDA?

The inspection ran Mar 13 – Mar 19, 2024, and the Form 483 is dated March 19, 2024.

How do I get the full Form 483 for Actavis Laboratories UT, Inc.?

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