Form 483 · FEI 3010450840
Form 483 issued November 5, 2013 · South Lyon, Michigan
- Inspection
- Oct 21 – Nov 5, 2013
- Investigators
- Jeffrey D. Meng· Michele L. Forster
- Observations
- 6
- Pages
- 4
- FEI number
- 3010450840
In short: On November 5, 2013, FDA issued a Form 483 with 6 observations to an FDA-inspected site in South Lyon, Michigan (FEI 3010450840) after an inspection that ran Oct 21 – Nov 5, 2013. The investigators were Jeffrey D. Meng and Michele L. Forster. Most observations concern laboratory controls and production.
At a glance
Laboratory controls and production account for 5 of 6 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 sanitized 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
Laboratory controls do not include the establishment of scientifically sound and appropriate sampling plans and test…
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 6 observations on this Form 483, mostly about laboratory controls, production and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected an FDA-inspected site?
Jeffrey D. Meng and Michele L. Forster are named on this Form 483, for the inspection of Oct 21 – Nov 5, 2013. Each investigator has a profile showing what they cite most.
When was an FDA-inspected site inspected by FDA?
The inspection ran Oct 21 – Nov 5, 2013, and the Form 483 is dated November 5, 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.