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FDA Inspections, Warning Letters and Import Refusals: South Africa

FDA has recorded 290 inspections of firms in South Africa, 9 of them (3.1%) classified OAI. It has issued 10 warning letters to firms there and refused 2,038 import shipments. 99 firms in South Africa are named on FDA import alerts.

OAI (Official Action Indicated) means FDA recommends regulatory and/or administrative action after an inspection. A warning letter is FDA's formal notice of significant violations. An import refusal is a shipment FDA refused entry to the United States.

All countries · Check one supplier with the free FDA compliance check.

By year

The last 10 calendar years (2017 to 2026, 2026 so far). FDA adds classified inspections and posts actions months after they happen, so recent years can still grow.

South Africa: FDA inspections per year 2017: 22 inspections2220172018: 22 inspections2220182019: 21 inspections2120192020: 10 inspections1020202021: 0 inspections020212022: 13 inspections1320222023: 32 inspections3220232024: 11 inspections1120242025: 21 inspections2120252026: 28 inspections282026
YearInspectionsOAIOAI shareWarning lettersImport refusals
20262813.6%132
20252100.0%248
202411436.4%145
20233200.0%099
20221300.0%019
202100011
20201000.0%233
20192100.0%059
20182200.0%029
20172229.1%156

Latest OAI inspections

DateFacilityProduct type
Jul 14, 2026Aspen SA Sterile Operations (Pty) Ltd.Drugs
Sep 23, 2024Marshalls Traditional Healthcare CCDrugs
Sep 17, 2024Aspen SA Sterile Operations (Pty) Ltd.Drugs
Mar 14, 2024Associated Fruit Processors (Pty) Ltd.Food/Cosmetics
Mar 14, 2024Western Cape Fruit Processors (Pty) LtdFood/Cosmetics
Aug 9, 2017Granor Passi Langkloof (Pty) LtdFood/Cosmetics
Jul 25, 2017Rhodes Food Group (Pty) Ltd.Food/Cosmetics
Jul 8, 2015Rhodes Food Group (Pty) Ltd.Food/Cosmetics
Oct 7, 2010Southern Implants, (Pty.) Ltd.Devices

Latest warning letters

DateFirmProduct typeFDA center
Jun 17, 2026HADASSAH HEALING ODrugsCDER
Feb 24, 2025Aspen SA Sterile Operations (Pty) Ltd.DrugsCDER
Feb 10, 2025Marshalls Traditional Healthcare CCDrugsCDER
Nov 21, 2024Catwalk Cosmetic Laboratories Pty Ltd.DrugsCDER
Aug 3, 2020MMStabs.ComDrugsCDER
Apr 22, 2020Black Industries Pty LtdTobaccoCTP
Oct 6, 2017Rhodes Food Group (Pty) Ltd.Food/CosmeticsCFSAN
Feb 4, 2016Rhodes Food Group (Pty) Ltd.Food/CosmeticsCFSAN
May 29, 2014Www.Cigaretteshouse.ComTobaccoCTP
Nov 17, 2009Hunter, DDrugsCDER

Search every letter by company with the FDA warning letter search.

Latest import refusals

DateFirmProduct category
Oct 20, 2026ENVIRON SKIN CARE (PTY) LTD (Prev. Environ Cosmeceutics CC)Cosmetics
Oct 5, 2026Tiger Brands LtdHuman Foods
Oct 1, 2026Adcock IngramDrugs and Biologics
Sep 25, 2026Tiger Brands LtdHuman Foods
Sep 25, 2026Tiger Consumer BrandsHuman Foods
Sep 18, 2026Tiger Consumer BrandsHuman Foods
Sep 18, 2026Tiger Consumer Brands Pty LtdHuman Foods
Aug 5, 2026OCKSAN TRADING PTY LTD T/A AVIOMEDHuman Foods
Aug 5, 2026OCKSAN TRADING PTY LTD T/A AVIOMEDHuman Foods
Aug 5, 2026OCKSAN TRADING PTY LTD T/A AVIOMEDHuman Foods
Aug 5, 2026OCKSAN TRADING PTY LTD T/A AVIOMEDHuman Foods
Aug 5, 2026OCKSAN TRADING PTY LTD T/A AVIOMEDHuman Foods
Aug 5, 2026OCKSAN TRADING PTY LTD T/A AVIOMEDHuman Foods
Aug 5, 2026OCKSAN TRADING PTY LTD T/A AVIOMEDHuman Foods
Aug 5, 2026OCKSAN TRADING PTY LTD T/A AVIOMEDHuman Foods
Aug 5, 2026OCKSAN TRADING PTY LTD T/A AVIOMEDHuman Foods
Aug 5, 2026OCKSAN TRADING PTY LTD T/A AVIOMEDHuman Foods
Aug 5, 2026OCKSAN TRADING PTY LTD T/A AVIOMEDHuman Foods
Aug 5, 2026OCKSAN TRADING PTY LTD T/A AVIOMEDHuman Foods
Aug 5, 2026OCKSAN TRADING PTY LTD T/A AVIOMEDHuman Foods
Jun 29, 2026Johnson And Johnson (PTY) Ltd.Drugs and Biologics
Jun 29, 2026Johnson And Johnson (PTY) Ltd.Drugs and Biologics
Jun 29, 2026Aspen PharmacareDrugs and Biologics
May 22, 2026Tiger Consumer BrandsHuman Foods
May 5, 2026Mondelez South Africa (Pty) LtdHuman Foods

Showing the latest 25 of 2,038.

Firms on FDA import alerts

PublishedFirmImport alertList
Oct 29, 2026Tiger Brands Ltd99-37red
May 19, 2026Tiger Brands99-08red
May 19, 2026Tiger Consumer Brands99-08red
Mar 30, 2026Jigsimur SA Original66-41red
Jan 14, 2026MONSTER ENERGY BEVERAGE COMPANY OF SOUTH AFRICA (PTY) LTD45-02red
Jul 10, 2025OPHTHALMICA PTY LTD68-19red
Jul 10, 2025Southern Implants, (Pty.) Ltd.68-19red
Jul 10, 2025SOUTHERN MEDICAL (PTY) LTD68-19red
May 21, 2025Continental China Pty Limited99-45red
Apr 3, 2025Oryx K971-04red
Feb 10, 2025Aspen SA Sterile Operations (Pty) Ltd.66-40red
Nov 18, 2024Catwalk Cosmetic Laboratories Pty Ltd.66-40red
Oct 1, 2024PAU YUEN TONG & CO66-41red
Sep 26, 2024Mondelez South Africa (Pty) Ltd45-02red
May 6, 2024JIGSIMUR HEALTH PLUS DRINK66-41red
Apr 15, 2024Rhodes Food Group Pty Ltd45-02red
Mar 15, 2024HEALTHYLIFE CAPETOWN66-41red
Aug 15, 2022Institute For Vision Improvement89-08red
Aug 2, 2022OPHTHALMICA PTY LTD66-41red
Aug 2, 2022SOUTHERN MEDICAL (PTY) LTD66-41red
Jul 17, 2020ICT INTERNATIONAL89-08red
Jul 8, 2020Multi Mineral Supplement66-41red
Jul 8, 2020MULTI MINERAL SUPPLEMENT66-41red
Jul 8, 2020MULTI MINERAL SUPPLEMENT66-41red
Jul 8, 2020MULTI MINERAL SUPPLEMENT66-41red

Showing the latest 25 of 99.

Most-inspected facilities

FacilityCityInspectionsOAILatest
Aspen SA Sterile Operations (Pty) Ltd.Port Elizabeth62Jul 14, 2026
Lacsa (Pty) LimitedDurban South40Jul 24, 2026
NTP Radioisotopes SOC Ltd.Brits40Apr 11, 2025
Fine Chemicals Corporation (PTY), Ltd.Goodwood40Apr 4, 2025
Aspen SA OSD Operations Pty Ltd.Korsten40Dec 8, 2017
Cape Herb & Spice - A Division Of Libstar Operations (Pty) LtdCape Town30May 2, 2023
Cape Hothouse Vegetables CCMalmesbury30Apr 26, 2023
Prof. Johnny MahlanguJohannesburg30Mar 17, 2023
Southern Implants, (Pty.) Ltd.Irene, Gauteng31Jan 28, 2016
Biochemical And Scientific Consultants CcHilton20Jul 20, 2026
Prof. Bernardo Leon RapoportJohannesburg20Jan 29, 2026
FARMOVS PTY Ltd.Bloemfontein20Oct 17, 2025
Lesley J. Burgess, MB. Ch. B., M. Med., Ph. D.Parow20Sep 12, 2025
Frederick J. Raal, FCP(SA), PhD, MDJohannesburg20Sep 4, 2025
Nyda Fourie, MDBloemfontein20Jun 13, 2025

See each facility's Form 483 observations with the FDA 483 search.

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