Belcher Pharmaceuticals, LLC
Form 483 issued August 16, 2024 · Largo, Florida
- Inspection
- Aug 7 – Aug 16, 2024
- Investigators
- Jessica P. McAlister· Kayla V. Sprague
- Observations
- 6
- Pages
- 5
- FEI number
- 1000526113
In short: On August 16, 2024, FDA issued a Form 483 with 6 observations to Belcher Pharmaceuticals, LLC in Largo, Florida (FEI 1000526113) after an inspection that ran Aug 7 – Aug 16, 2024. The investigators were Jessica P. McAlister and Kayla V. Sprague. Most observations concern laboratory controls and facilities & equipment; the most-cited regulation is 21 CFR 211.167 (special testing requirements).
At a glance
Laboratory controls and facilities & equipment account for 4 of 6 observations.
Most cited: 21 CFR 211.167 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Each batch of controlled-release dosage form drug product is not laboratory tested to determine conformance to…
- 02
Each batch of dmg product required to be free of objectionable niicroorganisms is not tested…
- 03
Observation 3: scanned text, readable in the full document.
- 04
Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air…
This inspection in context
Jessica P. McAlister
7 documents · 2021–2024
Cites FDCA 501(a)(2)(A) (insanitary conditions) more than any other section. Most of their documents are for sites in Florida.
The firmBelcher Pharmaceuticals, LLC history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.167
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Belcher Pharmaceuticals, LLC?
FDA listed 6 observations on this Form 483, mostly about laboratory controls, facilities & equipment and packaging & labeling. The most-cited regulation is 21 CFR 211.167 (special testing requirements). The opening words of each observation are shown on this page.
Who inspected Belcher Pharmaceuticals, LLC?
Jessica P. McAlister and Kayla V. Sprague are named on this Form 483, for the inspection of Aug 7 – Aug 16, 2024. Each investigator has a profile showing what they cite most.
When was Belcher Pharmaceuticals, LLC inspected by FDA?
The inspection ran Aug 7 – Aug 16, 2024, and the Form 483 is dated August 16, 2024.
How do I get the full Form 483 for Belcher Pharmaceuticals, LLC?
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.