FDA Intel

Innovative Compounding Pharmacy

Form 483 issued April 17, 2015 · Folsom, California

Inspection
Apr 13 – Apr 17, 2015
Investigators
Daniel J. Roberts· Linda F. Murphy
Observations
10
Pages
6
FEI number
3011396023

In short: On April 17, 2015, FDA issued a Form 483 with 10 observations to Innovative Compounding Pharmacy in Folsom, California (FEI 3011396023) after an inspection that ran Apr 13 – Apr 17, 2015. The investigators were Daniel J. Roberts and Linda F. Murphy. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.42 (design and construction features).

At a glance

Facilities & equipment and laboratory controls account for 8 of 10 observations.

Facilities & equipment5
Laboratory controls3
Production2

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)(v)

    Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room…

  3. 03
    21 CFR 211.42(c)(10)(iv)

    Aseptic processing areas are deficient regarding the system…

  4. 04
    21 CFR 211.113(b)

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

6 more observations

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

Get the full 483

This inspection in context

The investigator

Daniel J. Roberts

14 documents · 2011–2017

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

The firm

Innovative Compounding Pharmacy 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 Innovative Compounding Pharmacy?

FDA listed 10 observations on this Form 483, mostly about facilities & equipment, laboratory controls and production. 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 Innovative Compounding Pharmacy?

Daniel J. Roberts and Linda F. Murphy are named on this Form 483, for the inspection of Apr 13 – Apr 17, 2015. Each investigator has a profile showing what they cite most.

When was Innovative Compounding Pharmacy inspected by FDA?

The inspection ran Apr 13 – Apr 17, 2015, and the Form 483 is dated April 17, 2015.

How do I get the full Form 483 for Innovative Compounding Pharmacy?

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