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Federal record

FDA Warning Letter issued July 10, 2018 · FDA closed it out on January 5, 2023. Read the close-out letter →

Lee Silsby Pharmacy
Compounding Pharmacy

Lee Silsby Pharmacy

Reviewed by Vial Editorial · October 1, 2026

OH · Serves 43 states

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Lee Silsby Pharmacy is a compounding pharmacy available in 43 states. The FDA issued a warning letter involving Lee Silsby Pharmacy on July 10, 2018, closed out on January 5, 2023. Pricing was not publicly listed, so total cost should be confirmed before signing up.

What they offerCompounding Pharmacy

69/100
Why this score?

The Vial Score measures how much of this provider's public record Vial could confirm, and how clearly the provider discloses it. It does not measure quality of care.

85-100High Confidence
70-84Well Documented
50-69Limited Confidence
0-49Flagged

Lee Silsby Pharmacy scores 69, in the Limited Confidence band. The score moves when the public record changes. For Lee Silsby Pharmacy, the item most likely to move it: Pricing.

Payment never changes a score.

6 of 8 checks complete. The remaining checks have not been run yet. Missing checks reduce how complete the profile is. They are not a finding by themselves.

Score history

  1. 69July 2026Vial scoring update
  2. 77June 2026Record updated
  3. 53June 2026Record updated
  4. 60June 2026Vial scoring update
  5. 53May 2026Record updated
  6. 51May 2026

What we found on Lee Silsby Pharmacy

We reviewed FDA enforcement records, OIG exclusions, DEA registration, HIPAA breach records, NPI registration, PCAB accreditation, and FDA 503B registration.

The FDA issued a warning letter involving Lee Silsby Pharmacy on July 10, 2018, and closed it out on January 5, 2023. Read the details below. The company serves 43 states. We could not independently verify a third-party certification or accreditation as of October 2026.

Why this score: 6 of 8 checks complete. Each links to the public source it was verified against.

Federal actions
Confirmed. See the full report for detail.
See the full report for the details of this record.
FDA.govFDA close-out letterOIG LEIEDEA DiversionHHS OCR Portal
Checked October 14, 2026
Pricing
Not publicly listed
Not publicly listed. Confirm total monthly cost before enrolling.
Physicians named
Not publicly identified
NPI registration
No NPI match found in the federal registry as of 2026-10-05.
confirms a recognized healthcare entity in the federal registry.
CMS NPI Registry
Checked October 5, 2026
PCAB accreditation
No PCAB accreditation on file as of 2026-06-04.
PCAB is the primary accreditation standard for compounding pharmacies.
ACHC / PCAB
Checked June 4, 2026
FDA 503B registration
Not on the FDA 503B outsourcing registry as of 2026-10-05 (most compounders operate under 503A).
503B registration applies to outsourcing facilities; most compounders operate under 503A.
FDA 503B Registry
Checked October 5, 2026
LegitScript certification
Not checked yet
not found is not failed. It means unconfirmed.
States served
43 of 50
Listed as available in 43 of 50 states. Confirm availability for your state before signing up.
Show all evidence (8) Show fewer

A check we haven’t completed yet is not a mark against this provider. It just means we’re still sourcing that record. The score reflects what we’ve confirmed so far, and updates as more checks come in.

Vial describes the record, not the provider. This is not a medical recommendation or endorsement. Last reviewed October 1, 2026.

Our take

Vial Editorial

Based on the records and public materials we reviewed.

Lee Silsby is a 503A compounding pharmacy in Beachwood, Ohio, known for the medications it makes for autism and integrative medicine practices. Since 2023 it has been owned by Revelation Pharma. They don't publish prices; each preparation is quoted against a prescription.

The FDA issued a warning letter to Gipsco Investment Corp, then doing business as Lee Silsby Compounding Pharmacy, on July 10, 2018 and closed it out on January 5, 2023. The letter is published at https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/gipsco-investment-corp-557802-07102018, and the close-out at https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/gipsco-investment-corporation-dba-lee-silsby-compounding-pharmacy-557802-01052023. We found no recalls, no OIG exclusion and no PCAB accreditation. They display a LegitScript badge we haven't confirmed. Their shipping page lists licenses in 43 jurisdictions. The patient reviews we found average 4.5 from 178, mostly Google reviews.

6 of 8 key checks found
2 important details still need to be confirmed directly.

What it costs

Lee Silsby publishes no prices. Not a partial list, not a starting figure, nothing. For a 503A compounding pharmacy that is a category norm rather than a failing, because each preparation is made to a specific prescription and cost depends on the drug, strength, dosage form and quantity. Everything requires a prescription from a licensed prescriber. The pharmacy does not prescribe and there is no built-in telehealth consultation, so a patient brings a prescription or a prescriber sends one. Prescriptions can be submitted through the website and refills requested online. The company's own frequently asked questions state that compounded prescriptions are sometimes covered by insurance, that coverage is plan specific, and that the pharmacy can supply documentation to support a claim. In practice many patients pay at the point of sale and seek reimbursement afterwards. Typical turnaround is given as roughly 24 to 48 hours, longer than a retail refill because the medication is made rather than picked off a shelf, and refrigerated items may need overnight or two day shipping. Anyone who needs a number before committing has to call and ask for a quote on their specific formula. As of 21 September 2026 there is no published price list to compare against.

Sources: leesilsby.com · leesilsby.com · leesilsby.com

What patients report

Public sentiment is positive and reasonably deep for a single-location pharmacy. Checked 21 September 2026, the Birdeye aggregator showed 4.5 out of 5 across 178 reviews, drawn from 136 Google reviews, 40 Birdeye reviews and 2 Foursquare reviews, with new reviews posted within the previous month. The Better Business Bureau lists the business at A plus and records it as not accredited, with a file opened 4 June 2008 and Steven Dufala named as managing pharmacist. Complaint counts were not displayed in the content retrieved on that date, so the volume of formal complaints could not be established either way. Recurring positive themes are staff courtesy, willingness to explain a formulation, speed relative to expectations for a made-to-order medication, and consistency for people filling the same unusual prescription month after month. The recurring negative theme is communication, meaning callbacks, order status and coordination with prescribers. Two things are worth separating. Patient reports describe service and responsiveness. They say nothing about sterile compounding quality, which is what the FDA inspection record addresses. A warm review has no bearing on an autoclave log. Read the two records side by side rather than letting one stand in for the other.

Sources: birdeye.com · bbb.org

What the record means

Vial scores Lee Silsby Pharmacy 69 out of 100, Limited Confidence.

Records checked 21 September 2026. Lee Silsby is a 503A compounding pharmacy. It does not appear on the FDA list of registered 503B outsourcing facilities, current as of 8 September 2026. That distinction matters, because 503A pharmacies compound against individual prescriptions and are not subject to the same manufacturing-standard oversight as 503B facilities. The FDA inspected the predecessor entity, Gipsco Investment Corp doing business as Lee Silsby Compounding Pharmacy, in June 2017 and issued a warning letter on 10 July 2018. It cited compounding with melatonin, which is not the subject of a monograph and is not on the 503A bulk substances list, a non-sterile gown sleeve resting on ISO-5 work surfaces, non-pharmaceutical grade material used over sterile glutathione preparations, an unsealed clean room ceiling light fixture, and autoclave cycles failing to reach required temperatures between August 2016 and March 2017. The FDA closed the letter out on 5 January 2023. The letter is published at https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/gipsco-investment-corp-557802-07102018, and the close-out at https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/gipsco-investment-corporation-dba-lee-silsby-compounding-pharmacy-557802-01052023. We found no recall entries, no OIG exclusion and no HHS breach entry. No PCAB or ACHC accreditation was found and none is claimed. The site displays a LegitScript badge that we could not confirm independently. The shipping page states licensure to 43 jurisdictions with six more listed as coming soon.

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Compare record details

Lee Silsby Pharmacy's FDA warning letter was closed out on January 5, 2023; RC Outsourcing LLC has an FDA warning letter with no close-out letter found.

Lee Silsby Pharmacy scores 69, RC Outsourcing LLC scores 38.

Lee Silsby PharmacyRC Outsourcing LLC
Federal actionsConfirmedConfirmed
Vial Score69/10038/100
LegitScript certifiedNoNo
PCAB accreditedNoNo
States served43 statesNot checked

What Vial measures, and what we don’t

We evaluate public records: federal enforcement history, registrations, certifications, and how transparent a provider is about its clinicians, pharmacies, and pricing. We don’t score bedside manner, clinical outcomes, or customer satisfaction, and we don’t collect user reviews.

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Sources reviewed as of October 2026

This page evaluates compliance signals, not clinical outcomes. Consult a licensed physician before starting any therapy, medication, or treatment. Vial does not provide medical advice.