Delta Pharma, Inc.
Form 483 issued May 20, 2022 · Ripley, Mississippi
- Inspection
- May 10 – May 20, 2022
- Investigators
- Jennifer Lalama· Regan T. Harp
- Observations
- 5
- Pages
- 4
- FEI number
- 3004034796
In short: On May 20, 2022, FDA issued a Form 483 with 5 observations to Delta Pharma, Inc. in Ripley, Mississippi (FEI 3004034796) after an inspection that ran May 10 – May 20, 2022. The investigators were Jennifer Lalama and Regan T. Harp. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
4 of 5 observations on this 483 concern facilities & equipment.
What FDA observed
Preview: the opening words of each observation- 01
Clothing of personnel engaged in the processing of drug products is not appropriate for…
- 02
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
- 03
Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to aseptic…
- 04
Routine calibration of equipment is not performed according to a written program designed…
This inspection in context
Jennifer Lalama
31 documents · 2015–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Florida.
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 211.28(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Delta Pharma, Inc.?
FDA listed 5 observations on this Form 483, mostly about facilities & equipment and production. 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.?
Jennifer Lalama and Regan T. Harp are named on this Form 483, for the inspection of May 10 – May 20, 2022. Each investigator has a profile showing what they cite most.
When was Delta Pharma, Inc. inspected by FDA?
The inspection ran May 10 – May 20, 2022, and the Form 483 is dated May 20, 2022.
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.