Class IITerminated · reported 2022-06-15

CB1102052 BOCATA ESPECIAL CASERO'S

GRUVIPA S.L. recalled this product and the FDA reported the enforcement action on 15 June 2022 as Class II. The recall was initiated by the firm. Finished product potentially adulterated with insect filth.

The record

Every field below is published by the FDA in the openFDA food enforcement database. Check the FDA notice before acting on any recall: this page is a reading of the public record, not a substitute for it.

Product
CB1102052 BOCATA ESPECIAL CASERO'S
Reason for recall
Finished product potentially adulterated with insect filth.
Recalling firm
GRUVIPA S.L.
Firm location
Pineda De Mar, Spain
Classification
Class II
Status
Terminated
Recall number
F-1278-2022
Quantity
116,160 units
Distribution
Domestic distribution only (Florida).
Initiated
23 May 2022
Reported by FDA
15 June 2022
Terminated
23 August 2022
Firm notified by
Telephone
Product codes
LOT Best By Date 21443 Jul 24, 2022 21493 Aug 28, 2022 21494 Aug 29, 2022 21511 Sep 9, 2022 21511 Sep 9, 2022 22043 Oct 16, 2022 22044 Oct 17, 2022 22045 Oct 18, 2022 22052 Oct 22, 2022 22054 Oct 24, 2022 22043 Oct 16, 2022 22044 Oct 17, 2022 22052 Oct 22, 2022 22054 Oct 24, 2022 22063 Oct 30, 2022 22064 Oct 31, 2022 22065 Nov 1, 2022 22065 Nov 1, 2022 22073 Nov 6, 2022 22075 Nov 8, 2022 22081 Nov 8, 2022 22084 Nov 14, 2022 22085 Nov 15, 2022 22093 Nov 20, 2022 22094 Nov 22, 2022 22094 Nov 21, 2022 22124 Dec 12, 2022 22125 Dec 16, 2022 22126 Dec 16, 2022 22126 Dec 16, 2022 22142 Dec 24, 2022 22144 Dec 26, 2022 22152 Dec 31, 2022 22153 Jan 1 2023 22161 Jan 6, 2023 22162 Jan 7, 2023

Reading this record

Five things about this record are not in the record itself, and each one changes how it should be read.

  • Class II means the FDA judged a remote probability of serious harm, or a probability of temporary or medically reversible harm. The class is assigned by an agency health hazard evaluation under 21 CFR 7.41, not by the firm.
  • The firm started this recall itself. Most FDA food recalls are voluntary, and a recall is a food safety plan working rather than failing. The circumstances in which the agency asks for one instead are set out in 21 CFR 7.45.
  • This is one of 6 records covering the same recall event. The FDA opens one enforcement record per product code, so a recall of a product line appears here many times. Counting these records as 6 separate recalls, which almost every published figure does, overstates it by a factor of 6. Every product code in this event is listed together on the record that covers the whole recall, which is the page a search engine is pointed to for all 6 of them.
  • The recall ran for 3 months, from 23 May 2022 to termination on 23 August 2022. Termination means the agency judged that all reasonable effort had been made, under 21 CFR 7.55, and it says nothing about whether product remained in circulation.
  • The FDA published the enforcement report 3 weeks after the firm began the recall.
  • The product description on this record names no food this site can classify, so it appears on no food-type page. That is a limit of the description rather than of the recall.

What this recall was for

Foreign material

A foreign material recall means something that is not food was found in food: metal, plastic, glass, wood or insect matter, usually shed by equipment during processing.

A preventive controls plan covers foreign material under the clauses below. This is where the control belongs, not a finding against any firm named on this page: a recall record states a reason, and most of these recalls were initiated by the firm itself.

21 CFR 117.40
Equipment and utensils: plant equipment designed and maintained so it cannot contaminate food with lubricants, fuel, metal fragments or contaminated water.
21 CFR 117.80(c)
Manufacturing operations: the measures that protect food from contamination during processing, including the effective ones against metal and other extraneous material.
21 CFR 117.150
Corrective actions: what a facility does when a preventive control was not properly implemented, including identifying and correcting the problem and evaluating the food for safety.

Unapproved ingredients

An unapproved ingredient recall means a product contained a substance not permitted in food, most often an undisclosed pharmaceutical active found in a dietary supplement.

A preventive controls plan covers an unapproved ingredient under the clauses below. This is where the control belongs, not a finding against any firm named on this page: a recall record states a reason, and most of these recalls were initiated by the firm itself.

21 CFR 111
Dietary supplement CGMP: the identity, purity, strength and composition specifications a supplement manufacturer sets and verifies for every component and finished batch.
21 CFR 117 subpart G
Supply-chain programme: the approval and verification a receiving facility runs on a supplier when the hazard is controlled before the ingredient arrives.

Other records from GRUVIPA S.L.

The FDA opens one enforcement record per product code, so several of these are frequently one recall event. 5 other records name this firm.

ReportedProductFirmReasonClass
2022-06-15CB1115007 SILVESTRE CEREALESGRUVIPA S.L.Finished product potentially adulterated with insect filth.Class II
2022-06-15CB1101006 BARRA LARGA CON SALVADOGRUVIPA S.L.Finished product potentially adulterated with insect filth.Class II
2022-06-15CB1101004 BAGUETTE SUPER and CB1101005 BAGUETTE SUPER (34 u.)GRUVIPA S.L.Finished product potentially adulterated with insect filth.Class II
2022-06-15CB1102006 BOCATA 120GRUVIPA S.L.Finished product potentially adulterated with insect filth.Class II
2022-06-15CB1101001 BARRA XXLGRUVIPA S.L.Finished product potentially adulterated with insect filth.Class II

All 6 records for GRUVIPA S.L.

All 2022 recalls · All FDA food recall data

21 CFR 117.40 is the clause behind this recall, and it is one somebody has to produce evidence for at their next audit. Krolda maps supplier documents to the clause they satisfy in FSSC 22000, IFS Food and 21 CFR 117, and routes the corrective action when the evidence is missing.

Early access

Recall records come from the openFDA food enforcement API, published by the U.S. Food and Drug Administration in the public domain. Krolda adds the hazard classification and the clause mapping; neither is an FDA determination. Always check the FDA notice before acting on a recall.