MedPREP Consulting Inc.
Form 483 issued April 3, 2013 · Tinton Falls, New Jersey
- Inspection
- Mar 15 – Apr 3, 2013
- Investigators
- Barbara J. Wilimczyk-Macri· James A. Liubicich· Jose M. Cayuela
- Observations
- 13
- Pages
- 8
- FEI number
- 3002902471
In short: On April 3, 2013, FDA issued a Form 483 with 13 observations to MedPREP Consulting Inc. in Tinton Falls, New Jersey (FEI 3002902471) after an inspection that ran Mar 15 – Apr 3, 2013. The investigators were Barbara J. Wilimczyk-Macri, James A. Liubicich, Jose M. Cayuela and Russell J. Glapion. 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 8 of 13 observations.
Most cited: 21 CFR 211.42 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
Laboratory controls do not include the establishment of scientifically sound and appropriate sampling plans and test…
- 03
An adequate number of batches of each drug product are not tested to determine…
- 04
Reserve drug product samples are not retained and stored under conditions…
This inspection in context
Barbara J. Wilimczyk-Macri
5 documents · 2012–2016
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in New Jersey.
The firmMedPREP Consulting Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at MedPREP Consulting Inc.?
FDA listed 13 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 MedPREP Consulting Inc.?
Barbara J. Wilimczyk-Macri, James A. Liubicich, Jose M. Cayuela and Russell J. Glapion are named on this Form 483, for the inspection of Mar 15 – Apr 3, 2013. Each investigator has a profile showing what they cite most.
When was MedPREP Consulting Inc. inspected by FDA?
The inspection ran Mar 15 – Apr 3, 2013, and the Form 483 is dated April 3, 2013.
How do I get the full Form 483 for MedPREP Consulting Inc.?
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.