MedPREP Consulting Inc.
FDA inspection history in Tinton Falls, New Jersey, 2010 to 2013
- 1
- Form 483
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2010: one warning letter; 2013: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2010One warning letter, at Tinton Falls, New Jersey.
- 2013One Form 483, at Tinton Falls, New Jersey.
Cited most
Across all MedPREP Consulting observations on file
- 21 CFR 211.42Design and construction features3
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.113Control of microbiological contamination1
- 21 CFR 211.160General requirements1
- 21 CFR 211.166Stability testing1
The complete MedPREP Consulting file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Tinton Falls, New Jersey
One Form 483 and one warning letter · 2010 to 2013 · 13 observations
Latest: Form 483, Apr 3, 2013 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2013-04-03 | 483 Form 483 | Tinton Falls, New Jersey | 13 | $99 |
| 2010-07-09 | Warning letter Warning letter | Tinton Falls, New Jersey | — | $99 |
Investigators on these documents
Barbara J. Wilimczyk-Macri (1)James A. Liubicich (1)Jose M. Cayuela (1)Russell J. Glapion (1)
FEI number 3002902471 · most recent document Apr 3, 2013
About MedPREP Consulting Inc.
How many FDA Form 483s has MedPREP Consulting Inc. received?
FDA Intel has 1 Form 483 on file for MedPREP Consulting Inc.; the most recent is dated Apr 3, 2013.
When was MedPREP Consulting Inc. last inspected by FDA?
The most recent FDA inspection document on file for MedPREP Consulting Inc. is a Form 483 dated Apr 3, 2013, for the site in Tinton Falls, New Jersey.
What did FDA cite at MedPREP Consulting Inc.?
The regulations cited most in the observations on file for MedPREP Consulting Inc. are 21 CFR 211.42 (Design and construction features), 3 times; 21 CFR 211.100 (Written procedures; deviations), 1 time; 21 CFR 211.113 (Control of microbiological contamination), 1 time.
Has MedPREP Consulting Inc. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for MedPREP Consulting Inc.; the most recent is dated Jul 9, 2010.