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Exact Medical Manufacturing, Inc. FDA Inspection Record

FEI 3008011779 · Inspections, Form 483s, warning letters and import refusals

Exact Medical Manufacturing, Inc. is an FDA-inspected facility (FEI 3008011779) located in Lancaster, NY, US. RegDataLab tracks 3 FDA inspections at this facility.

What FDA found at this site

Latest inspection
Jul 12, 2023: No Action Indicated (NAI)
Inspections on record
3 (1 VAI, 2 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
1, latest Apr 29, 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
Jul 12, 2023No Action Indicated (NAI)No citations listed
Mar 11, 2021Voluntary Action Indicated (VAI)Design input - documentation (21 CFR 820.30(c))
Lack of or inadequate procedures (21 CFR 820.100(a))
Design validation - user needs and intended uses (21 CFR 820.30(g))
Nov 21, 2017No Action Indicated (NAI)Training - Lack of or inadequate procedures (21 CFR 820.25(b))
Lack of or inadequate procedures (21 CFR 820.100(a))
Document review, approval documentation (21 CFR 820.40(a))

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
Apr 29, 2021Class IIZ-1907-2021Probe Cover 6" x 48" regular PE w/ 2 Elastic Bands-Ultrasonic Transducer Cover Bulk… and 17 more products
No 510k for the product to be used in a natural or surgical opening to the body

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
Exact Medical Manufacturing, Inc.
Location
Lancaster, NY (US)
Source
inspections

FDA data resources

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