Willow Birch Pharma, Inc
Form 483 issued October 28, 2016 · Taylor, Mississippi
- Inspection
- Oct 19 – Oct 28, 2016
- Investigator
- Marvin D. Jones
- Observations
- 6
- Pages
- 4
- FEI number
- 3009864247
In short: On October 28, 2016, FDA issued a Form 483 with 6 observations to Willow Birch Pharma, Inc in Taylor, Mississippi (FEI 3009864247) after an inspection that ran Oct 19 – Oct 28, 2016. The investigator was Marvin D. Jones. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.188 (batch production and control records).
At a glance
Observations span 4 systems, led by production.
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit…
- 02
Equipment for adequate control over air pressure, humidity and temperature is not provided when appropriate for…
- 03
A system by which the distribution of each lot of drug product can be readily determined…
- 04
The batch production and control records are deficient in that they are not an accurate reproduction…
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 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 211.22(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Willow Birch Pharma, Inc?
FDA listed 6 observations on this Form 483, mostly about production, quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.188 (batch production and control records). The opening words of each observation are shown on this page.
Who inspected Willow Birch Pharma, Inc?
Marvin D. Jones is named on this Form 483, for the inspection of Oct 19 – Oct 28, 2016. Each investigator has a profile showing what they cite most.
When was Willow Birch Pharma, Inc inspected by FDA?
The inspection ran Oct 19 – Oct 28, 2016, and the Form 483 is dated October 28, 2016.
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.