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TURNCARE, INC. — FDA Facility Profile

FEI 3013682457

TURNCARE, INC. is an FDA-registered facility (FEI 3013682457) located in Pompton Plains, NJ, US. RegDataLab tracks 2 FDA inspections at this facility.

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What FDA found at this site

Latest inspection
Dec 11, 2024: No Action Indicated (NAI)
Inspections on record
2 (1 VAI, 1 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
2, latest Nov 1, 2023

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
Dec 11, 2024No Action Indicated (NAI)Report of violation of the Act (see 803.52(e)(9)) (21 CFR 806.10(a)(2))
Jun 26, 2023Voluntary Action Indicated (VAI)Quality audits - Lack of or inadequate procedures (21 CFR 820.22)
Training - Lack of or inadequate procedures (21 CFR 820.25(b))
Lack of or inadequate procedures (21 CFR 820.100(a))
Lack of or inadequate DHR procedures (21 CFR 820.184)
and 5 more

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 1, 2023Not yet classifiedZ-1967-2025Brand Name: Guardian 2 System Product Name: Guardian System 2 Controller Model/Catalog…
A software issue where "low" and "terminal" battery alerts did not display on the screen to the user in specific circumstances when the…
Aug 10, 2023Not yet classifiedZ-1968-2025Brand Name: Guardian 2 System Product Name: Guardian System 2 Controller Model/Catalog…
A software update corrected an issue where "low" and "terminal" battery alerts did not display on the screen to the user in specific…

Facility details

Company
Turncare, Inc
Location
Pompton Plains, NJ (US)
Source
device

FDA data resources

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