FDA Intel

I.V. Specialty Ltd.

Form 483 issued February 5, 2016 · Austin, Texas

Inspection
Jan 28 – Feb 5, 2016
Investigators
Massoud Motamed· Shelby N. Marler
Observations
8
Pages
8
FEI number
3010836489

In short: On February 5, 2016, FDA issued a Form 483 with 8 observations to I.V. Specialty Ltd. in Austin, Texas (FEI 3010836489) after an inspection that ran Jan 28 – Feb 5, 2016. The investigators were Massoud Motamed and Shelby N. Marler. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).

At a glance

Facilities & equipment and production account for 6 of 8 observations.

Facilities & equipment4
Production2
Laboratory controls1
Quality system1

What FDA observed

Preview: the opening words of each observation
  1. 01
    21 CFR 211.42(c)(10)(vi)

    Aseptic processing areas are deficient regarding systems for maintaining any equipment used to…

  2. 02
    21 CFR 211.167(a)

    Each batch ofdrug product purporting to be sterile and pyrogen-free is not laboratory tested to determine…

  3. 03
    21 CFR 211.28(a)

    Clothing of personnel engaged in the manufacturing, processing, packing and holding of drug products is not…

  4. 04
    21 CFR 211.113(b)

    Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…

4 more observations

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

Get the full 483

This inspection in context

The investigator

Massoud Motamed

20 documents · 2015–2025

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

The firm

I.V. Specialty Ltd. history

All 4 documents on file for this site, in date order, with what was cited at each inspection.

Similar 483s

Other sites cited under 211.42(c)(10)(vi)

See how FDA wrote the same problem up elsewhere.

Questions about this 483

What did FDA find at I.V. Specialty Ltd.?

FDA listed 8 observations on this Form 483, mostly about facilities & equipment, production and laboratory controls. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.

Who inspected I.V. Specialty Ltd.?

Massoud Motamed and Shelby N. Marler are named on this Form 483, for the inspection of Jan 28 – Feb 5, 2016. Each investigator has a profile showing what they cite most.

When was I.V. Specialty Ltd. inspected by FDA?

The inspection ran Jan 28 – Feb 5, 2016, and the Form 483 is dated February 5, 2016.

How do I get the full Form 483 for I.V. Specialty Ltd.?

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.

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