Form 483 · FEI 3009641885
Form 483 issued July 19, 2013 · Southfield, Michigan
- Inspection
- Jul 1 – Jul 19, 2013
- Investigators
- Jeffrey D. Meng· Sarah M. Napier· Sheryl A. Duquet
- Observations
- 13
- Pages
- 9
- FEI number
- 3009641885
In short: On July 19, 2013, FDA issued a Form 483 with 13 observations to an FDA-inspected site in Southfield, Michigan (FEI 3009641885) after an inspection that ran Jul 1 – Jul 19, 2013. The investigators were Jeffrey D. Meng, Sarah M. Napier and Sheryl A. Duquet. Most observations concern production and laboratory controls.
At a glance
Production and laboratory controls account for 8 of 13 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
- 02
Equipment and utensils are not cleaned, maintained, and sani.tized at appropriate intervals to prevent contamination that…
- 03
There are no written procedures for production and process controls designed to assure that the drug…
- 04
Each batch ofdrug product purporting to be sterile and pyrogen-free is not laboratory tested to determine…
This inspection in context
Jeffrey D. Meng
14 documents · 2010–2016
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Michigan.
The firmSite history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at an FDA-inspected site?
FDA listed 13 observations on this Form 483, mostly about production, laboratory controls and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected an FDA-inspected site?
Jeffrey D. Meng, Sarah M. Napier and Sheryl A. Duquet are named on this Form 483, for the inspection of Jul 1 – Jul 19, 2013. Each investigator has a profile showing what they cite most.
When was an FDA-inspected site inspected by FDA?
The inspection ran Jul 1 – Jul 19, 2013, and the Form 483 is dated July 19, 2013.
How do I get the full Form 483 for an FDA-inspected site?
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.