FDA Intel

Pharmacy Creations

Form 483 issued August 19, 2013 · Randolph, New Jersey

Inspection
Aug 5 – Aug 19, 2013
Investigators
Douglas C. Kovacs· Michael R. Klapal
Observations
5
Pages
2
FEI number
3003348498

In short: On August 19, 2013, FDA issued a Form 483 with 5 observations to Pharmacy Creations in Randolph, New Jersey (FEI 3003348498) after an inspection that ran Aug 5 – Aug 19, 2013. The investigators were Douglas C. Kovacs and Michael R. Klapal. Most observations concern laboratory controls and production.

At a glance

Laboratory controls and production account for 3 of 5 observations.

Laboratory controls2
Production1
Materials1
Facilities & equipment1

What FDA observed

Preview: the opening words of each observation
  1. 01
    21 CFR 211.166(b)

    An adequate number of batches of each drug product are not tested to determine…

  2. 02
    21 CFR 211.113(b)

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

  3. 03
    21 CFR 211.94(c)

    Drug product containers were not steri lized and processed to r emove pyrogenic properties to assure…

  4. 04
    21 CFR 211.167(a)

    Each batch of drug product purporting to be sterile is not laboratory tested to determine…

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

Douglas C. Kovacs

3 documents · 2006–2013

Cites 211.113(b) (control of microbiological contamination) more than any other section. Most of their documents are for sites in New Jersey.

The firm

Pharmacy Creations history

All 7 documents on file for this site, in date order, with what was cited at each inspection.

Similar 483s

Other sites cited under 211.166(b)

See how FDA wrote the same problem up elsewhere.

Questions about this 483

What did FDA find at Pharmacy Creations?

FDA listed 5 observations on this Form 483, mostly about laboratory controls, production and materials. The opening words of each observation are shown on this page.

Who inspected Pharmacy Creations?

Douglas C. Kovacs and Michael R. Klapal are named on this Form 483, for the inspection of Aug 5 – Aug 19, 2013. Each investigator has a profile showing what they cite most.

When was Pharmacy Creations inspected by FDA?

The inspection ran Aug 5 – Aug 19, 2013, and the Form 483 is dated August 19, 2013.

How do I get the full Form 483 for Pharmacy Creations?

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