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Miracles In Sight FDA Inspection Record

FEI 3001237888 · Inspections, Form 483s, warning letters and import refusals

Miracles In Sight is an FDA-inspected facility (FEI 3001237888) located in Winston Salem, NC, US. RegDataLab tracks 8 FDA inspections at this facility.

What FDA found at this site

Latest inspection
Mar 10, 2025: No Action Indicated (NAI)
Inspections on record
8 (2 VAI, 6 NAI)
Last OAI inspection
None on record
Warning letters
None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
Recalls as the recalling firm
5, latest Nov 30, 2021

A Form 483 lists an inspector's observations. OAI means FDA recommends regulatory and/or administrative action. A warning letter is FDA's formal enforcement notice. No record here does not establish that a site is safe. Check this site on FDA's Data Dashboard.

Inspections and what FDA cited

Newest first. Citations are the inspector observations FDA publishes for the inspection.

DateResultWhat FDA cited
Mar 10, 2025No Action Indicated (NAI)No citations listed
Sep 18, 2023No Action Indicated (NAI)No citations listed
Jan 30, 2020No Action Indicated (NAI)No citations listed
Aug 11, 2017No Action Indicated (NAI)No citations listed
Sep 23, 2015No Action Indicated (NAI)No citations listed
Feb 26, 2014Voluntary Action Indicated (VAI)All core requirements covered in program (21 CFR 1271.160(a))
Procedures to meet core CTGP (21 CFR 1271.180(a))
Clean, sanitary, orderly manner (21 CFR 1271.190(b)(1))
Mar 14, 2012No Action Indicated (NAI)No citations listed
Jul 9, 2009Voluntary Action Indicated (VAI)Identified as quarantined, distinguishable (21 CFR 1271.60(b))

Recalls

Newest first. Recalls FDA's Enforcement Report lists with this FEI as the recalling firm. The recalling firm is not always the site that made the product. Search FDA's Enforcement Report by recall number.

DateClassRecallProduct and reason
Nov 30, 2021Class IIB-0125-2022Cornea
Corneas, in which donor testing was conducted with an unacceptable sample, were distributed.
Feb 18, 2016Class IIIB-0613-16Cornea
Human cornea, recovered without verifying supplies and reagents met specifications for use, and was distributed.
Mar 15, 2013Class IIIB-1494-13Cornea
Human Corneas, recovered using an expired Prep Kit, were distributed.
Mar 11, 2013Class IIB-1432-13Cornea
Human corneal allograft was processed in a manner that could cause contamination or cross-contamination during processing, and well as the…
Mar 31, 2000Class IB-1639-4Human Cornea Tissues for Transplantation
Human tissue for transplantation, which was subsequently found to test repeatedly reactive for the hepatitis B surface antigen (HBsAg), was…

FDA record score

2 of 100. A count of this site's adverse public FDA records, weighted by how recent each one is. A higher number means more, or more recent, records. Each record below adds the points shown.

Counted on Nov 14, 2026, method version 1. It counts records and does not judge the site: a low number does not establish that a site is safe, and sites that FDA inspects more often can collect more points. How this is counted.

5 records behind this number
RecordDatePoints x age weightAdds
Class II recall B-0125-2022, this FEI as the recalling firmNov 30, 20214 x 0.62.4
Inspection classified VAIFeb 26, 201410 years or older, so it adds no points0
Class II recall B-1432-13, this FEI as the recalling firmMar 11, 201310 years or older, so it adds no points0
Inspection classified VAIJul 9, 200910 years or older, so it adds no points0
Class I recall B-1639-4, this FEI as the recalling firmMar 31, 200010 years or older, so it adds no points0

When each source was last refreshed

FDA sources behind this page and when RegDataLab last refreshed each one
RecordsLast refreshedSource as ofStatus
InspectionsNov 14, 2026Newest record Nov 5, 2026Current
Inspection citationsNov 14, 2026Newest record Nov 5, 2026Current
Compliance actions (warning letters, injunctions and other action types)Nov 2, 2026Newest record Oct 29, 2026Current
Warning letter textNov 14, 2026Newest record Nov 10, 2026Current
Recalls (Enforcement Report)Nov 14, 2026Newest record Nov 11, 2026Current
Form 483s and inspection documentsNov 13, 2026Newest record Nov 12, 2026Current
Import refusalsNov 2, 2026Newest record Oct 22, 2026Current

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Facility details

Company
Miracles In Sight
Location
Winston Salem, NC (US)
Source
inspections

FDA data resources

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.