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CHROMSYSTEMS INSTRUMENTS & CHEMICALS GMBH FDA Inspection Record

FEI 3003951180 · Inspections, Form 483s, warning letters and import refusals

CHROMSYSTEMS INSTRUMENTS & CHEMICALS GMBH is an FDA-registered facility (FEI 3003951180) located in Gräfelfing Bavaria, DE. RegDataLab tracks 2 FDA inspections and 1 compliance action at this facility.

What FDA found at this site

Latest inspection
Jun 23, 2016: No Action Indicated (NAI)
Inspections on record
2 (1 OAI, 1 NAI)
Last OAI inspection
Mar 20, 2014
Warning letters
1 listed by FDA for this FEI, latest Aug 8, 2014
Recalls as the recalling firm
3, latest May 19, 2022
Import refusals
9

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
Jun 23, 2016No Action Indicated (NAI)No citations listed
Mar 20, 2014Official Action Indicated (OAI)Lack of or inadequate receiving acceptance procedures (21 CFR 820.80(b))
Investigation of device failures (21 CFR 820.198(c))
Sampling plans (21 CFR 820.250(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
May 19, 2022Class IIZ-1336-2022MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level I and 1 more product
Too low concentration of glycine was detected in the dried blood controls of the batch 2821 of the products.
Nov 2, 2020Class IIZ-0536-20213PLUS1 Multilevel Plasma Calibrator Set, Order No. 75128 - Product Usage: The kit is… and 3 more products
Products do not meet stability criteria and may impact results.
Oct 29, 2020Class IIZ-0521-20216PLUS1 Multilevel Saliva Calibrator Set Cortisol Cortisone in Saliva, Order No. 73039… and 2 more products
Calibrator lots may not meet stability criteria and could result in increased results of patient samples for cortisone.

FDA record score

4 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 Z-1336-2022, this FEI as the recalling firmMay 19, 20224 x 0.62.4
Class II recall Z-0536-2021, this FEI as the recalling firmNov 2, 20204 x 0.251
Class II recall Z-0521-2021, this FEI as the recalling firmOct 29, 20204 x 0.251
Warning letter on FDA's dashboard, which does not show close-outsAug 8, 201410 years or older, so it adds no points0
Inspection classified OAIMar 20, 201410 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
Chromsystems Instruments & Chemicals GmbH
Location
Gräfelfing Bavaria (DE)
Source
device

Compliance actions

Import refusals

FDA data resources

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