Form 483
Form 483 issued July 7, 2016 · Burlington, Kentucky
- Inspection
- Jun 30 – Jul 7, 2016
- Investigator
- Jennifer L. Gustavus
- Observations
- 4
- Pages
- 2
- FEI number
- 3006358789
In short: On July 7, 2016, FDA issued a Form 483 with 4 observations to an FDA-inspected site in Burlington, Kentucky (FEI 3006358789) after an inspection that ran Jun 30 – Jul 7, 2016. The investigator was Jennifer L. Gustavus. Most observations concern packaging & labeling and quality system.
At a glance
Packaging & labeling and quality system account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
Written procedures for the identification, storage and handling of packaging and labeling…
- 02
Procedures designed to assure that correct labels, labeling and packaging materials are used for drug…
- 03
Employees are not given training in…
- 04
There are no written procedures for production and process controls designed to assure that the drug…
This inspection in context
Jennifer L. Gustavus
2 documents · 2016
Cites 211.100(a) (written procedures; deviations) more than any other section. Most of their documents are for sites in India.
The firmSite history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.122(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at an FDA-inspected site?
FDA listed 4 observations on this Form 483, mostly about packaging & labeling, quality system and production. The opening words of each observation are shown on this page.
Who inspected an FDA-inspected site?
Jennifer L. Gustavus is named on this Form 483, for the inspection of Jun 30 – Jul 7, 2016. Each investigator has a profile showing what they cite most.
When was an FDA-inspected site inspected by FDA?
The inspection ran Jun 30 – Jul 7, 2016, and the Form 483 is dated July 7, 2016.
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.