Delta Pharma, Inc.
Form 483 issued May 24, 2016 · Ripley, Mississippi
- Inspection
- May 16 – May 24, 2016
- Investigators
- Marvin D. Jones· Zada L. Giles
- Observations
- 9
- Pages
- 5
- FEI number
- 3004034796
In short: On May 24, 2016, FDA issued a Form 483 with 9 observations to Delta Pharma, Inc. in Ripley, Mississippi (FEI 3004034796) after an inspection that ran May 16 – May 24, 2016. The investigators were Marvin D. Jones and Zada L. Giles. Most observations concern production and laboratory controls.
At a glance
Production and laboratory controls account for 7 of 9 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 do not include…
- 02
Aseptic processing areas are deficient regarding the system…
- 03
Routine calibration of equipment is not performed according to a written program designed…
- 04
Testing and release of drug product for distribution do ·not include appropriate laboratory determination of satisfactory…
This inspection in context
Marvin D. Jones
22 documents · 2007–2025
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Mississippi.
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
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 production, laboratory controls and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Delta Pharma, Inc.?
Marvin D. Jones and Zada L. Giles are named on this Form 483, for the inspection of May 16 – May 24, 2016. Each investigator has a profile showing what they cite most.
When was Delta Pharma, Inc. inspected by FDA?
The inspection ran May 16 – May 24, 2016, and the Form 483 is dated May 24, 2016.
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.