Facility

CUSTOM ASSEMBLIES, INC.

1 recall(s) on record — most severe on record: Class II.

Key facts

1recalls · worst Class II

4inspections · worst OAI

1warning letters

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3000718854
Establishment type	Manufacture Medical Device
Location	330 EAST MAIN STREET PINE LEVEL, NC, US 27568
Registration status	Active · expires 2026
Parent company	CUSTOM ASSEMBLIES, INC. (owner-operator 9026626)
Brand names	Container, Specimen, Non-Sterile

Activity by year

Recalls (1)
Inspections (4)
Warning letters (1)

Devices registered here (1)

Container, Specimen, Non-Sterile
Product code NNI (opens in a new tab) · Class I · Pathology · 21 CFR 864.3250

Recalls & enforcement

Class IITerminated2017-06-15
The firm manufactured and distributed custom surgical kits which contained BD SafetyGlide" 22GA 1® inch Needles. BD subsequently recalled these needles because, " Loose polypropylene particulate in the fluid path could be expelled out of the needle during injection.

FDA inspections (4)

NAI2025-07-24
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
VAI2022-10-06
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
VAI2019-07-19
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
OAI2017-07-31
Official Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

FDA warning letters (1)

Warning Letter2018-04-06
Warning Letter (opens in a new tab) · Pine Level North Carolina

Source: U.S. FDA Compliance Actions Dashboard (opens in a new tab) (device warning letters, 2016–present). Data as of 2026-10-06. Each link opens an FDA search for the letter; FDA can take several weeks to post a letter, so a very recent one may not appear yet.

All facilities operated by CUSTOM ASSEMBLIES, INC.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “CUSTOM ASSEMBLIES, INC. (FEI 3000718854) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3000718854-custom-assemblies-inc/

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