FDA Intel

The Compounding Pharmacy of America

Form 483 issued May 21, 2015 · Knoxville, Tennessee

Inspection
May 12 – May 21, 2015
Investigators
Marvin D. Jones· Zada L. Giles
Observations
16
Pages
10
FEI number
3011504027

In short: On May 21, 2015, FDA issued a Form 483 with 16 observations to The Compounding Pharmacy of America in Knoxville, Tennessee (FEI 3011504027) after an inspection that ran May 12 – May 21, 2015. The investigators were Marvin D. Jones and Zada L. Giles. 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 10 of 16 observations.

Facilities & equipment6
Production4
Laboratory controls2
Materials2
Other2

What FDA observed

Preview: the opening words of each observation
  1. 01
    21 CFR 211.167(a)

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

  2. 02
    21 CFR 211.94(c)

    Drug product containers and closures were not clean and sterilized and processed to remove pyrogenic properties…

  3. 03
    21 CFR 211.113(b)

    Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…

  4. 04
    21 CFR 211.42(c)(10)(iv)

    Aseptic processing areas are deficient regarding the system…

12 more observations

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

Get the full 483

This inspection in context

The investigator

Marvin D. Jones

22 documents · 2007–2025

Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Mississippi.

The firm

The Compounding Pharmacy of America history

All 5 documents on file for this site, in date order, with what was cited at each inspection.

Similar 483s

Other sites cited under 211.167(a)

See how FDA wrote the same problem up elsewhere.

Questions about this 483

What did FDA find at The Compounding Pharmacy of America?

FDA listed 16 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 The Compounding Pharmacy of America?

Marvin D. Jones and Zada L. Giles are named on this Form 483, for the inspection of May 12 – May 21, 2015. Each investigator has a profile showing what they cite most.

When was The Compounding Pharmacy of America inspected by FDA?

The inspection ran May 12 – May 21, 2015, and the Form 483 is dated May 21, 2015.

How do I get the full Form 483 for The Compounding Pharmacy of America?

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