Home / Facilities / 2082295

SATO PHARMACEUTICAL, INC. — FDA Facility Profile

FEI 2082295

SATO PHARMACEUTICAL, INC. is an FDA-registered facility (FEI 2082295) located in TORRANCE, CA, US. RegDataLab tracks 2 FDA inspections at this facility.

Reviewing SATO PHARMACEUTICAL, INC. as a supplier? Request a free FDA snapshot: name up to five suppliers and get a PDF of their public FDA record, with sources and dates. You do not need an API connection. Each snapshot is prepared by hand.

Check this supplier

Or check SATO PHARMACEUTICAL, INC. yourself in Claude, Cursor or ChatGPT: get the full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site.

Get a free API key

What FDA found at this site

Latest inspection
Dec 21, 2010: No Action Indicated (NAI)
Inspections on record
2 (2 NAI)
Last OAI inspection
None on record
Warning letters
None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
Recalls as the recalling firm
4, latest Mar 12, 2026

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
Dec 21, 2010No Action Indicated (NAI)No citations listed
May 18, 2010No Action Indicated (NAI)No citations listed

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
Mar 12, 2026Class IIIH-0892-2026Yunker(branded) Energy & Health Herbal Supplement with Vitamins; Manufactured by Sato…
Product does not meet label claim for Vitamin E.
Oct 1, 2019Class IIID-0303-2020Sankaijo BOTANICAL LAXATIVE (docusate sodium 8.33 mg and sennosides 1.36 mg) tablets…
Subpotent Drug: Formulated amount of sennosides component is less than labelled claim.
Oct 1, 2019Class IIID-0322-2020Zentrip (meclizine Hydrochloride), 25 mg strips, 8-strips per box, Distributed by Sato… and 3 more products
Subpotent Drug
Feb 16, 2017Class IID-0854-2017Optic Splash (naphazoline hydrochloride) Eye Drops, packaged in 0.5 FL OZ (15mL) bottles… and 2 more products
Lack of Assurance of Sterility: Firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing…

Facility details

Company
Sato Pharmaceutical Inc.
Location
TORRANCE, CA (US)
Source
device

FDA data resources

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