Health Dimensions, Inc.
Form 483 issued August 8, 2014 · Farmington Hills, Michigan
- Inspection
- Jul 31 – Aug 8, 2014
- Investigator
- Jeffrey D. Meng
- Observations
- 5
- Pages
- 3
- FEI number
- 3004575469
In short: On August 8, 2014, FDA issued a Form 483 with 5 observations to Health Dimensions, Inc. in Farmington Hills, Michigan (FEI 3004575469) after an inspection that ran Jul 31 – Aug 8, 2014. The investigator was Jeffrey D. Meng. Most observations concern production and facilities & equipment.
At a glance
Production and facilities & equipment account for 3 of 5 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
- 02
Time limits are not established when appropriate for the completion of each production phase to assure…
- 03
Aseptic processing areas are deficient regarding the system…
- 04
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
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 firmHealth Dimensions, Inc. history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Health Dimensions, Inc.?
FDA listed 5 observations on this Form 483, mostly about production, facilities & equipment and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Health Dimensions, Inc.?
Jeffrey D. Meng is named on this Form 483, for the inspection of Jul 31 – Aug 8, 2014. Each investigator has a profile showing what they cite most.
When was Health Dimensions, Inc. inspected by FDA?
The inspection ran Jul 31 – Aug 8, 2014, and the Form 483 is dated August 8, 2014.
How do I get the full Form 483 for Health Dimensions, 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.