Belmar Pharmacy
Form 483 issued July 10, 2015 · Lake wood, Colorado
- Inspection
- Jun 10, 2020
- Investigators
- Erika V. Butler· Zachery L. Miller
- Observations
- 6
- Pages
- 5
- FEI number
- 3005727550
In short: On July 10, 2015, FDA issued a Form 483 with 6 observations to Belmar Pharmacy in Lake wood, Colorado (FEI 3005727550) after an inspection that ran Jun 10, 2020. The investigators were Erika V. Butler and Zachery L. Miller. Most observations concern laboratory controls and production.
At a glance
Laboratory controls and production account for 5 of 6 observations.
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 products purporting to be sterile do not include…
- 02
Each batch of drug product purporting to be sterile and pyrogen-free is not laboratory tested to…
- 03
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 04
The written stability program for drug products does not include reliable, meaningful…
This inspection in context
Erika V. Butler
23 documents · 2007–2019
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Colorado.
The firmBelmar Pharmacy history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Belmar Pharmacy?
FDA listed 6 observations on this Form 483, mostly about laboratory controls, production and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Belmar Pharmacy?
Erika V. Butler and Zachery L. Miller are named on this Form 483, for the inspection of Jun 10, 2020. Each investigator has a profile showing what they cite most.
When was Belmar Pharmacy inspected by FDA?
The inspection ran Jun 10, 2020, and the Form 483 is dated July 10, 2015.
How do I get the full Form 483 for Belmar Pharmacy?
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.