Delta Pharma, Inc.
Form 483 issued February 23, 2017 · Ripley, Mississippi
- Inspection
- Feb 13 – Feb 23, 2017
- Investigators
- Brandon C. Heianeier· Brandon C. Heitrueier· C. Heitmeier
- Observations
- 12
- Pages
- 7
- FEI number
- 3004034796
In short: On February 23, 2017, FDA issued a Form 483 with 12 observations to Delta Pharma, Inc. in Ripley, Mississippi (FEI 3004034796) after an inspection that ran Feb 13 – Feb 23, 2017. The investigators were Brandon C. Heianeier, Brandon C. Heitrueier, C. Heitmeier and Shelby N. Marler. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Observations span 4 systems, led by production.
Most cited: 21 CFR 211.42 (3×) · 211.166 (2×)
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 product purporting to be sterile do not include…
- 02
Drug product containers and closures were not clean, sterilized, and processed to remove pyrogenic properties to…
- 03
Clothing of personnel engaged in the processing of injectable drug products is not appropriate for…
- 04
Aseptic processing areas are deficient regarding the system…
This inspection in context
Brandon C. Heianeier
1 document · 2017
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 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Delta Pharma, Inc.?
FDA listed 12 observations on this Form 483, mostly about production, facilities & equipment and laboratory controls. 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.?
Brandon C. Heianeier, Brandon C. Heitrueier, C. Heitmeier and Shelby N. Marler are named on this Form 483, for the inspection of Feb 13 – Feb 23, 2017. Each investigator has a profile showing what they cite most.
When was Delta Pharma, Inc. inspected by FDA?
The inspection ran Feb 13 – Feb 23, 2017, and the Form 483 is dated February 23, 2017.
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.