FocusLaboratories
Form 483 issued February 5, 2015 · North Little Rock, Arkansas
- Inspection
- Jan 26 – Feb 5, 2015
- Investigators
- Camerson E. Moore· Hung V. Le
- Observations
- 10
- Pages
- 10
- FEI number
- 3008990081
In short: On February 5, 2015, FDA issued a Form 483 with 10 observations to FocusLaboratories in North Little Rock, Arkansas (FEI 3008990081) after an inspection that ran Jan 26 – Feb 5, 2015. The investigators were Camerson E. Moore and Hung V. Le. Most observations concern laboratory controls and quality system.
At a glance
Laboratory controls and quality system account for 8 of 10 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Accelerated stability studies, combined with basic stability information, used to support tentative expiration dates are not…
- 02
Batch production and control records do not include complete information relating to the production and…
- 03
Records are not maintained so that data therein can be reviewed at least annually to evaluate…
- 04
Acceptance criteria for the sampling and testing conducted by the quality control unit is not adequate…
This inspection in context
Camerson E. Moore
48 documents · 2014–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Texas.
The firmFocusLaboratories history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.166
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at FocusLaboratories?
FDA listed 10 observations on this Form 483, mostly about laboratory controls, quality system and production. The opening words of each observation are shown on this page.
Who inspected FocusLaboratories?
Camerson E. Moore and Hung V. Le are named on this Form 483, for the inspection of Jan 26 – Feb 5, 2015. Each investigator has a profile showing what they cite most.
When was FocusLaboratories inspected by FDA?
The inspection ran Jan 26 – Feb 5, 2015, and the Form 483 is dated February 5, 2015.
How do I get the full Form 483 for FocusLaboratories?
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.