Marietta Corporation
Form 483 issued June 15, 2015 · Cortland, New York
- Inspection
- Jun 8 – Jun 15, 2015
- Investigator
- Sasha M. Latonis
- Observations
- 4
- Pages
- 3
- FEI number
- 1317302
In short: On June 15, 2015, FDA issued a Form 483 with 4 observations to Marietta Corporation in Cortland, New York (FEI 1317302) after an inspection that ran Jun 8 – Jun 15, 2015. The investigator was Sasha M. Latonis. Most observations concern quality system and production.
At a glance
Quality system and production account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 02
Observation 2: scanned text, readable in the full document.
- 03
The written stability testing…
- 04
Written procedures are not followed for evaluations conducted at least(b) (4) to review records associated with…
This inspection in context
Sasha M. Latonis
2 documents · 2015
Cites 211.100(a) (written procedures; deviations) more than any other section. Most of their documents are for sites in New York.
The firmMarietta Corporation history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Marietta Corporation?
FDA listed 4 observations on this Form 483, mostly about quality system, production and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Marietta Corporation?
Sasha M. Latonis is named on this Form 483, for the inspection of Jun 8 – Jun 15, 2015. Each investigator has a profile showing what they cite most.
When was Marietta Corporation inspected by FDA?
The inspection ran Jun 8 – Jun 15, 2015, and the Form 483 is dated June 15, 2015.
How do I get the full Form 483 for Marietta Corporation?
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.