Delta Pharma, Inc.
Form 483 issued October 2, 2013 · Ripley, Mississippi
- Inspection
- Sep 24 – Oct 2, 2013
- Investigator
- Zada L. Giles
- Observations
- 9
- Pages
- 6
- FEI number
- 3004034796
In short: On October 2, 2013, FDA issued a Form 483 with 9 observations to Delta Pharma, Inc. in Ripley, Mississippi (FEI 3004034796) after an inspection that ran Sep 24 – Oct 2, 2013. The investigator was Zada L. Giles. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and production account for 7 of 9 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 do not include…
- 02
Aseptic processing areas are deficient regarding the system…
- 03
Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air…
- 04
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
This inspection in context
Zada L. Giles
9 documents · 2013–2016
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Tennessee.
The firmDelta Pharma, Inc. history
All 9 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 Delta Pharma, Inc.?
FDA listed 9 observations on this Form 483, mostly about facilities & equipment, production and materials. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Delta Pharma, Inc.?
Zada L. Giles is named on this Form 483, for the inspection of Sep 24 – Oct 2, 2013. Each investigator has a profile showing what they cite most.
When was Delta Pharma, Inc. inspected by FDA?
The inspection ran Sep 24 – Oct 2, 2013, and the Form 483 is dated October 2, 2013.
How do I get the full Form 483 for Delta Pharma, 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.