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Lotus Pharmaceutical Co., Ltd. Nantou Plant — FDA Facility Profile

FEI 3005999589

Lotus Pharmaceutical Co., Ltd. Nantou Plant is an FDA-registered facility (FEI 3005999589) located in TW. Registered operations: ANALYSIS; LABEL; MANUFACTURE; PACK. RegDataLab tracks 6 FDA inspections at this facility.

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What FDA found at this site

Latest inspection
Apr 12, 2024: Voluntary Action Indicated (VAI)
Inspections on record
6 (4 VAI, 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

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
Apr 12, 2024Voluntary Action Indicated (VAI)Authority lacking to review records, investigate errors (21 CFR 211.22(a))
Equipment Design, Size and Location (21 CFR 211.63)
Cleaning / Sanitizing / Maintenance (21 CFR 211.67(a))
Computer control of master formula records (21 CFR 211.68(b))
and 1 more
May 31, 2019No Action Indicated (NAI)No citations listed
Sep 22, 2017Voluntary Action Indicated (VAI)Investigations of discrepancies, failures (21 CFR 211.192)
Annual visual exams of drug products (21 CFR 211.170(b))
Drug products - samples representative, identified properly (21 CFR 211.160(b)(3))
Jun 4, 2015Voluntary Action Indicated (VAI)No citations listed
Aug 16, 2012No Action Indicated (NAI)No citations listed
Feb 11, 2010Voluntary Action Indicated (VAI)No citations listed

Facility details

Company
Lotus Pharmaceutical Co., Ltd.
Location
TW
Registration Expires
Dec 31, 2026
Operations
ANALYSIS; LABEL; MANUFACTURE; PACK
Source
decrs

FDA data resources

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