FacilityLedger

Device establishmentActive, RegisteredFDA warning letter on file

Microspecialties LLC

Microspecialties LLC is an FDA-registered device establishment (FEI 3002616700) located in Middletown, Connecticut. The facility is active, registered. Its most recent FDA inspection on record (2025-02-18) was classified NAI. FDA has issued 1 warning letter(s) to this facility.

FDA warning letter

May 8, 2025
CGMP/QSR/Medical Devices/Adulterated
Read the letter on FDA.gov ›

A warning letter is FDA's formal notice of significant violations that require prompt correction. It can hold up product approvals, trigger import alerts, and put supply agreements at risk until the issues are resolved and FDA closes it out.

Recalls (1)

Jun 5, 2024 Class II
Could not confirm products were exposed to the proper sterilization cycle can potentially cause post operative wound infection or injection site infection.
OngoingView source data ›

Recall data from openFDA enforcement reports (FDA Recall Enterprise System).

Establishment record

FEI Number
3002616700
Address
430 Smith St, Middletown, Connecticut
Establishment type
Device establishment
Products / operations
Ophthalmic, Manufacture Medical Device, General, Plastic Surgery, Manufacture Medical Device for Another Party (Contract Manufacturer), Complaint File Establishment per 21 CFR 820.198, Repack or Relabel Medical Device, General Hospital, Unknown, Orthopedic, Manufacture Device in the United States for Export Only
Registration status
Active, Registered

Verify this record in FDA source data ›

Inspection history

Inspections on file
Feb 18, 2025 · No Action Indicated (NAI)
Feb 18, 2025 · Official Action Indicated (OAI)
Sep 4, 2014 · Voluntary Action Indicated (VAI)
Feb 3, 2012 · No Action Indicated (NAI)
Feb 3, 2012 · Voluntary Action Indicated (VAI)
May 10, 2011 · Official Action Indicated (OAI)
Form 483 observations
Feb 18, 2025, 5 observations: Lack of or inadequate process validation; Lack of or inadequate final acceptance procedures; Documentation
Sep 4, 2014, 3 observations: Purchasing controls, Lack of or inadequate procedures; Lack of or inadequate complaint procedures; Environmental control Lack of or inadequate procedures
Feb 3, 2012, 4 observations: Process control procedures, Lack of or inadequate procedures; Documentation of validated process performance; Documentation - review in response to changes or deviations
May 10, 2011, 7 observations: Lack/Inad procedure-Monitoring/Control of Validated Proces; Lack of or inadequate In-process acceptance procedures; Lack of procedures, or not maintained

FDA record timeline

Warning letter
CGMP/QSR/Medical Devices/Adulterated
Source ›
FDA inspection
NAI classification
FDA inspection
OAI classification
Form 483
5 observations
Recall
Class II — Could not confirm products were exposed to the proper sterilization cycle can potentially cause post operative wound infection or injection site infection.
Source ›
FDA inspection
VAI classification
Form 483
3 observations
FDA inspection
NAI classification
FDA inspection
VAI classification
Form 483
4 observations
FDA inspection
OAI classification
Form 483
7 observations

Combined chronology of the public records shown on this page. FDA coverage varies by dataset and year.

Questions

Is Microspecialties LLC registered with the FDA?

Yes. Microspecialties LLC is an FDA-registered device establishment (FEI 3002616700) in Middletown, Connecticut. Its current registration status is Active, Registered.

Has Microspecialties LLC received an FDA warning letter?

Yes. FDA issued a warning letter to Microspecialties LLC; the most recent is dated May 8, 2025 (CGMP/QSR/Medical Devices/Adulterated).

What does Microspecialties LLC do?

Microspecialties LLC's FDA-registered operations are: Ophthalmic, Manufacture Medical Device, General, Plastic Surgery, Manufacture Medical Device for Another Party (Contract Manufacturer), Complaint File Establishment per 21 CFR 820.198, Repack or Relabel Medical Device, General Hospital, Unknown, Orthopedic, Manufacture Device in the United States for Export Only.

Related facilities

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Source: FDA public data · status as of 2026-08-22

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