# KOKUYO CO.,LTD. · 99-37 · JAPAN — FDA import alert red lists: firms subject to detention without physical examination

For KOKUYO CO.,LTD. · 99-37 · JAPAN, import alert is 99-37; import alert name is "DETENTION WITHOUT PHYSICAL EXAMINATION OF LOW-ACID CANNED FOODS AND ACIDIFIED FOODS WITHOUT FILED SCHEDULED PROCESSES"; country is JAPAN; product is Ready-to-eat, Shelf-stable, LACF, Whole Clams Packed in 100g Plastic Flexible Hermetically Sealed Pouches (Lake Shinji Shijimi Clams, Retort Shijimi Clam, Shijimi) | Ready-to-eat, Shelf-stable, LACF, Whole Clams Packed in 100g Plastic Flexible Hermetically Sealed Pouches (Lake Shinji Shijimi Clams, Retort Shijimi Clam, Shijimi); product code is 16 E - - 02 Clams | 16 X - - 30 Clams, Aquaculture Harvested Fishery/Seafood Products; date published is 08/17/2026; address is 1255 , Hikawachoshobara , Izumo, Shimane JAPAN, verified against its source on 2026-09-16.

- **Firm:** KOKUYO CO.,LTD. _(verified: appears in the quote below)_
- **Import alert:** 99-37
- **Import alert name:** "DETENTION WITHOUT PHYSICAL EXAMINATION OF LOW-ACID CANNED FOODS AND ACIDIFIED FOODS WITHOUT FILED SCHEDULED PROCESSES"
- **Country:** JAPAN _(verified: appears in the quote below)_
- **Address:** 1255 , Hikawachoshobara , Izumo, Shimane JAPAN _(verified: appears in the quote below)_
- **Date published:** 08/17/2026 _(verified: appears in the quote below)_
- **Product code:** 16 E - - 02 Clams | 16 X - - 30 Clams, Aquaculture Harvested Fishery/Seafood Products _(verified: each item appears in the quote below)_
- **Product:** Ready-to-eat, Shelf-stable, LACF, Whole Clams Packed in 100g Plastic Flexible Hermetically Sealed Pouches (Lake Shinji Shijimi Clams, Retort Shijimi Clam, Shijimi) | Ready-to-eat, Shelf-stable, LACF, Whole Clams Packed in 100g Plastic Flexible Hermetically Sealed Pouches (Lake Shinji Shijimi Clams, Retort Shijimi Clam, Shijimi) _(verified: each item appears in the quote below)_
- **FDA notes:** Initial FDA inspection of food manufacturing facility found serious deviations of the acidified food regulations (21 CFR Part 114). Based on FDA’s inspectional findings and review of the firm’s response, the FDA determined that the firm’s LACF, Whole Clams processed in the facility appears to be adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. The following violations are noted: 21 CFR 108.35(c)(1)-Requires registration, 21 CFR 108.35(c)(2)-Requires process filing, 21 CFR 108.35(g)-All operators shall be under the supervision of a person who has attended a school approved by the Commissioner, 21 CFR 108.35(f)-A commercial processor engaged in thermal processing of low-acid foods packaged in hermetically sealed containers shall have prepared and in his file plans for effecting recalls, 21 CFR 113.40(f)(1)-Requires that each retort in a low-acid canned food operations be equipped with at least one accurate temperature-indicating device, and 21 CFR 113.40(f)(2)(ii)- Records of the accuracy of the temperature-indicating device and of a reference device that is maintained. | Initial FDA inspection of food manufacturing facility found serious deviations of the acidified food regulations (21 CFR Part 114). Based on FDA’s inspectional findings and review of the firm’s response, the FDA determined that the firm’s LACF, Whole Clams processed in the facility appears to be adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. The following violations are noted: 21 CFR 108.35(c)(1)-Requires registration, 21 CFR 108.35(c)(2)-Requires process filing, 21 CFR 108.35(g)-All operators shall be under the supervision of a person who has attended a school approved by the Commissioner, 21 CFR 108.35(f)-A commercial processor engaged in thermal processing of low-acid foods packaged in hermetically sealed containers shall have prepared and in his file plans for effecting recalls, 21 CFR 113.40(f)(1)-Requires that each retort in a low-acid canned food operations be equipped with at least one accurate temperature-indicating device, and 21 CFR 113.40(f)(2)(ii)- Records of the accuracy of the temperature-indicating device and of a reference device that is maintained. _(verified: each item appears in the quote below)_

## What the source says

> KOKUYO CO.,LTD. Date Published : 08/17/2026 1255 , Hikawachoshobara , Izumo, Shimane JAPAN 16 E - - 02 Clams Date Published: 08/17/2026 Desc: Ready-to-eat, Shelf-stable, LACF, Whole Clams Packed in 100g Plastic Flexible Hermetically Sealed Pouches (Lake Shinji Shijimi Clams, Retort Shijimi Clam, Shijimi) Notes: Initial FDA inspection of food manufacturing facility found serious deviations of the acidified food regulations (21 CFR Part 114). Based on FDA’s inspectional findings and review of the firm’s response, the FDA determined that the firm’s LACF, Whole Clams processed in the facility appears to be adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. The following violations are noted: 21 CFR 108.35(c)(1)-Requires registration, 21 CFR 108.35(c)(2)-Requires process filing, 21 CFR 108.35(g)-All operators shall be under the supervision of a person who has attended a school approved by the Commissioner, 21 CFR 108.35(f)-A commercial processor engaged in thermal processing of low-acid foods packaged in hermetically sealed containers shall have prepared and in his file plans for effecting recalls, 21 CFR 113.40(f)(1)-Requires that each retort in a low-acid canned food operations be equipped with at least one accurate temperature-indicating device, and 21 CFR 113.40(f)(2)(ii)- Records of the accuracy of the temperature-indicating device and of a reference device that is maintained. 16 X - - 30 Clams, Aquaculture Harvested Fishery/Seafood Products Date Published: 08/17/2026 Desc: Ready-to-eat, Shelf-stable, LACF, Whole Clams Packed in 100g Plastic Flexible Hermetically Sealed Pouches (Lake Shinji Shijimi Clams, Retort Shijimi Clam, Shijimi) Notes: Initial FDA inspection of food manufacturing facility found serious deviations of the acidified food regulations (21 CFR Part 114). Based on FDA’s inspectional findings and review of the firm’s response, the FDA determined that the firm’s LACF, Whole Clams processed in the facility appears to be adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. The following violations are noted: 21 CFR 108.35(c)(1)-Requires registration, 21 CFR 108.35(c)(2)-Requires process filing, 21 CFR 108.35(g)-All operators shall be under the supervision of a person who has attended a school approved by the Commissioner, 21 CFR 108.35(f)-A commercial processor engaged in thermal processing of low-acid foods packaged in hermetically sealed containers shall have prepared and in his file plans for effecting recalls, 21 CFR 113.40(f)(1)-Requires that each retort in a low-acid canned food operations be equipped with at least one accurate temperature-indicating device, and 21 CFR 113.40(f)(2)(ii)- Records of the accuracy of the temperature-indicating device and of a reference device that is maintained.

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_1131.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).