Prescription Alternatives, Inc.
Form 483 issued November 16, 2018 · Frisco, Colorado
- Inspection
- Nov 13 – Nov 16, 2018
- Investigator
- Zachary L. Stamm
- Observations
- 6
- Pages
- 3
- FEI number
- 3014597508
In short: On November 16, 2018, FDA issued a Form 483 with 6 observations to Prescription Alternatives, Inc. in Frisco, Colorado (FEI 3014597508) after an inspection that ran Nov 13 – Nov 16, 2018. The investigator was Zachary L. Stamm. Most observations concern production and facilities & equipment.
At a glance
Observations span 4 systems, led by production.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to aseptic…
- 02
Protective apparel is not worn as necessary to protect drug products from…
- 03
Procedures designed to prevent microbiological contamination of drug products required to be…
- 04
The final containers/closures used for drug product required to be sterile were not…
This inspection in context
Zachary L. Stamm
13 documents · 2010–2025
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in Colorado.
The firmPrescription Alternatives, Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Prescription Alternatives, Inc.?
FDA listed 6 observations on this Form 483, mostly about production, facilities & equipment and materials. The opening words of each observation are shown on this page.
Who inspected Prescription Alternatives, Inc.?
Zachary L. Stamm is named on this Form 483, for the inspection of Nov 13 – Nov 16, 2018. Each investigator has a profile showing what they cite most.
When was Prescription Alternatives, Inc. inspected by FDA?
The inspection ran Nov 13 – Nov 16, 2018, and the Form 483 is dated November 16, 2018.
How do I get the full Form 483 for Prescription Alternatives, 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.