Distribuidora Comercial Jafra, S.A. De C.V. — FDA Facility Profile

FEI 3003029000

Distribuidora Comercial Jafra, S.A. De C.V. is an FDA-registered facility (FEI 3003029000) located in Queretaro, MX. Registered operations: LABEL; MANUFACTURE; PACK. RegDataLab tracks 4 FDA inspections at this facility.

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What FDA found at this site

Latest inspection
Nov 17, 2023: Voluntary Action Indicated (VAI)
Inspections on record
4 (4 VAI)
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
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
Nov 17, 2023Voluntary Action Indicated (VAI)Measured components for manufacturing (21 CFR 211.101(b))
Control procedures to monitor and validate performance (21 CFR 211.110(a))
Scientifically sound laboratory controls (21 CFR 211.160(b))
Sep 15, 2017Voluntary Action Indicated (VAI)No citations listed
Sep 29, 2014Voluntary Action Indicated (VAI)Cleaning / Sanitizing / Maintenance (21 CFR 211.67(a))
Absence of Written Procedures (21 CFR 211.100(a))
Label storage access limited to authorized personnel (21 CFR 211.122(d))
Written records kept in individual logs (21 CFR 211.182)
and 2 more
Jan 20, 2012Voluntary Action Indicated (VAI)No citations listed

Facility details

Company
Distribuidora Comercial Jafra S.A. De C.V.
Location
Queretaro (MX)
Registration Expires
Dec 31, 2027
Operations
LABEL; MANUFACTURE; PACK
Source
decrs

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