Willow Birch Pharma, Inc
Form 483 issued May 3, 2024 · Taylor, Mississippi
- Inspection
- Apr 30 – May 3, 2024
- Investigators
- Demario L. Walls· Megan Ziegler
- Observations
- 1
- Pages
- 3
- FEI number
- 3009864247
In short: On May 3, 2024, FDA issued a Form 483 with 1 observation to Willow Birch Pharma, Inc in Taylor, Mississippi (FEI 3009864247) after an inspection that ran Apr 30 – May 3, 2024. The investigators were Demario L. Walls and Megan Ziegler. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
1 of 1 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.68(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
This inspection in context
Demario L. Walls
18 documents · 2020–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Texas.
The firmWillow Birch Pharma, Inc history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.68(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Willow Birch Pharma, Inc?
FDA listed 1 observation on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected Willow Birch Pharma, Inc?
Demario L. Walls and Megan Ziegler are named on this Form 483, for the inspection of Apr 30 – May 3, 2024. Each investigator has a profile showing what they cite most.
When was Willow Birch Pharma, Inc inspected by FDA?
The inspection ran Apr 30 – May 3, 2024, and the Form 483 is dated May 3, 2024.
How do I get the full Form 483 for Willow Birch 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.