Deserving Health International Corp FDA Inspection Record

FEI 3012271380 · Inspections, Form 483s, warning letters and import refusals

Deserving Health International Corp is an FDA-registered facility (FEI 3012271380) located in Richmond, CA. Registered operations: MANUFACTURE. RegDataLab tracks 1 FDA inspection and 1 compliance action at this facility.

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What FDA found at this site

Latest inspection
Jul 14, 2017: Official Action Indicated (OAI)
Inspections on record
1 (1 OAI)
Last OAI inspection
Jul 14, 2017
Warning letters
1 listed by FDA for this FEI, latest Dec 18, 2017
Recalls as the recalling firm
1, latest Sep 20, 2017
Import refusals
10 or more

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
Jul 14, 2017Official Action Indicated (OAI)Procedures not in writing, fully followed (21 CFR 211.22(d))
Written procedures not established/followed (21 CFR 211.67(b))
Penicillin processing area not kept separate (21 CFR 211.42(d))
Component addition checked by 2nd person (21 CFR 211.101(d))
and 16 more

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
Sep 20, 2017Class IID-0011-2018Symbio Muc Eye, 0.17 fl.oz. 5mL bottles, Manufactured for and distributed in the US b…
Lack of Assurance of Sterility

Facility details

Company
Deserving Health International Corp
Location
Richmond (CA)
Registration Expires
Dec 31, 2027
Operations
MANUFACTURE
Source
decrs

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