C.J. Labs, Inc., Miami: FDA Inspections, Form 483s & Citations

Overview

8 FDA inspections are on record.
7 inspections produced a Form 483.
The most recent recorded inspection date is 2026-03-23.

At a glance

Inspections

Form 483s

EIRs

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

Inspection	Category	Outcome	Form 483
5 Feb 2026 – 23 Mar 2026	Foods & Cosmetics	483	On file
1 Oct 2024 – 15 Nov 2024	Foods & Cosmetics	483	View 483 →
23 Sep 2019 – 25 Sep 2019	Foods & Cosmetics	483	View 483 →
26 Sep 2016 – 29 Sep 2016	Foods & Cosmetics	483	View 483 →
30 May 2013 – 24 Jun 2013	Foods & Cosmetics	483	View 483 →
23 Oct 2012	Not recorded	483	View 483 →
24 Jun 2011	Not recorded	483	View 483 →
20 Jul 2007	Not recorded	Clean

Observations on record

Form 483 observations cited at this site, most recent first.

15 Nov 2024

21 CFR 111.103

Written procedures - establish; quality control operations

Cited by Benita C Okeke

15 Nov 2024

21 CFR 111.113(a)(1)

Quality control production, process control; material review, disposition

Cited by Benita C Okeke

15 Nov 2024

21 CFR 111.113(a)(2)

Quality control master manufacturing record; material review, disposition

Cited by Benita C Okeke

15 Nov 2024

21 CFR 111.120(e)

Quality control operations - quarantine

Cited by Benita C Okeke

15 Nov 2024

21 CFR 111.123(a)(7)

Quality control operations - finished batch, specifications

Cited by Benita C Okeke

Investigators

FDA investigators tied to this site in the record.

Benita C Okeke2 insp.

Rachel Peters2 insp.

Lourdes Andujar1 insp.

Linda K Matheny1 insp.

Jennifer Lalama1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

Citation	What it covers	Cited
21 CFR 111.403	Cited across public-safe Form 483 observations	4x
21 CFR 111.153	Cited across public-safe Form 483 observations	3x
21 CFR 111.75(a)(1)(i)	Cited across public-safe Form 483 observations	3x
21 CFR 111.103	Cited across public-safe Form 483 observations	2x
21 CFR 111.105	Cited across public-safe Form 483 observations	2x
21 CFR 111.205(c)	Cited across public-safe Form 483 observations	2x
21 CFR 111.255(b)	Cited across public-safe Form 483 observations	2x
21 CFR 111.27(b)	Cited across public-safe Form 483 observations	2x
21 CFR 111.75(a)(2)(ii)(A)	Cited across public-safe Form 483 observations	2x
21 CFR 111.75(c)	Cited across public-safe Form 483 observations	2x
21 CFR 111.83(b)(4)	Cited across public-safe Form 483 observations	2x
21 CFR 111.113(a)(1)	Cited across public-safe Form 483 observations	1x
21 CFR 111.113(a)(2)	Cited across public-safe Form 483 observations	1x
21 CFR 111.12	Cited across public-safe Form 483 observations	1x
21 CFR 111.120(e)	Cited across public-safe Form 483 observations	1x
21 CFR 111.123(a)(7)	Cited across public-safe Form 483 observations	1x
21 CFR 111.123(a)(8)	Cited across public-safe Form 483 observations	1x
21 CFR 111.123(b)(2)	Cited across public-safe Form 483 observations	1x
21 CFR 111.14(b)(1)	Cited across public-safe Form 483 observations	1x
21 CFR 111.15(k)	Cited across public-safe Form 483 observations	1x
21 CFR 111.155(c)	Cited across public-safe Form 483 observations	1x
21 CFR 111.16	Cited across public-safe Form 483 observations	1x
21 CFR 111.160(e)	Cited across public-safe Form 483 observations	1x
21 CFR 111.180(b)(3)(i)	Cited across public-safe Form 483 observations	1x
21 CFR 111.20(f)	Cited across public-safe Form 483 observations	1x
21 CFR 111.20(h)	Cited across public-safe Form 483 observations	1x
21 CFR 111.210	Cited across public-safe Form 483 observations	1x
21 CFR 111.210(h)(2)	Cited across public-safe Form 483 observations	1x
21 CFR 111.23(b)	Cited across public-safe Form 483 observations	1x
21 CFR 111.25	Cited across public-safe Form 483 observations	1x
21 CFR 111.25(c)	Cited across public-safe Form 483 observations	1x
21 CFR 111.255(c)	Cited across public-safe Form 483 observations	1x
21 CFR 111.260	Cited across public-safe Form 483 observations	1x
21 CFR 111.260(c)	Cited across public-safe Form 483 observations	1x
21 CFR 111.260(l)(1)(ii)	Cited across public-safe Form 483 observations	1x
21 CFR 111.315(a)	Cited across public-safe Form 483 observations	1x
21 CFR 111.315(b)	Cited across public-safe Form 483 observations	1x
21 CFR 111.315(d)	Cited across public-safe Form 483 observations	1x
21 CFR 111.315(e)	Cited across public-safe Form 483 observations	1x
21 CFR 111.320(b)	Cited across public-safe Form 483 observations	1x
21 CFR 111.35(b)(1)(iii)	Cited across public-safe Form 483 observations	1x
21 CFR 111.35(b)(6)	Cited across public-safe Form 483 observations	1x
21 CFR 111.353	Cited across public-safe Form 483 observations	1x
21 CFR 111.415(f)	Cited across public-safe Form 483 observations	1x
21 CFR 111.453	Cited across public-safe Form 483 observations	1x
21 CFR 111.475(b)(1)	Cited across public-safe Form 483 observations	1x
21 CFR 111.553	Cited across public-safe Form 483 observations	1x
21 CFR 111.560(c)	Cited across public-safe Form 483 observations	1x
21 CFR 111.605	Cited across public-safe Form 483 observations	1x
21 CFR 111.610(a)	Cited across public-safe Form 483 observations	1x
21 CFR 111.70(b)	Cited across public-safe Form 483 observations	1x
21 CFR 111.70(b)(2)	Cited across public-safe Form 483 observations	1x
21 CFR 111.70(d)	Cited across public-safe Form 483 observations	1x
21 CFR 111.70(e)	Cited across public-safe Form 483 observations	1x
21 CFR 111.75(a)(2)	Cited across public-safe Form 483 observations	1x

Full site report

Get the verbatim findings behind C.J. Labs, Inc.'s 7 Form 483s

Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.

The site's full inspection history, with every Form 483 and its outcome
Warning letters and recalls tied to the company behind it
Whether recurring CFR citations get closed out or repeat

C.J. Labs, Inc.

Overview

At a glance

Inspection history

Observations on record

Written procedures - establish; quality control operations

Quality control production, process control; material review, disposition

Quality control master manufacturing record; material review, disposition

Quality control operations - quarantine

Quality control operations - finished batch, specifications

Quality control - batch, product specifications

Components - quarantine

Master manufacturing record - record requirements

Equipment - establish written procedures

Batch record - each step

Batch record - required information

Instruments - calibration

Criteria for establishing specifications

Sampling plans; establish, follow

Standard reference materials; criteria for selecting

Examination, testing; established criteria

Examination, testing; scientifically valid

Batch, lot, control number

Product complaint - review, investigation

Records - keep: 1 year, 2 years

Records - available; FDA

Specifications - components

Specifications - labels, packaging

Specifications - finished dietary supplement

Component - verify identity, dietary ingredient

Appropriate tests, examinations; certificate of analysis

Instruments - calibration

Written procedures - quality control operations

Packaging, labels - contamination, deterioration

Document - required operation

Physical plant - screening against pests

Written procedures - cleaning

Specifications-component purity, strength, composition

Component - verify identity, dietary ingredient

Specifications met - verify; finished batch

Master manufacturing record - sampling, tests, examinations

Batch record - date, time; maintenance

Batch record - quality control; tests, examinations

Manufacturing operations - written procedures

Procedures - equipment - cleaning, sanitizing

Component - verify identity, dietary ingredient

Component - qualify supplier

Specifications met - verify; finished batch

Reserve sample - twice the quantity

Ensure quality; package, labeled, master record

Quality control - finished batch, distribution

Written procedures - components

Master manufacturing record: 1 year, 2 years

Batch record - complete

Written procedures - labeling operations

Written procedures -packaging operations

Written procedures - holding

Personnel - quality control personnel - qualified

Personnel - records - written procedures

Sanitation supervisors - assigned

Physical plant - bulbs, fixtures, skylights

Records - cleaning, pest control

Equipment, utensils; maintaining, cleaning, sanitizing

Documentation - equipment functions; intended use

Component - qualify supplier

Reserve sample - twice the quantity

Ensure quality; package, labeled, master record

Written procedures - components

Written procedures - product received; packaging, labeling

Master manufacturing record: 1 year, 2 years

Batch record - complete

Written procedures - labeling operations

Written procedures -packaging operations

Written procedures - holding; distributing

Written procedures - product complaint

Investigators

Recurring citations

Get the verbatim findings behind C.J. Labs, Inc.'s 7 Form 483s