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Procaps S.A.

FDA Regulatory Profile

Procaps S.A. has 0 FDA recalls, 5 inspections, 0 510(k) clearances and 0 compliance actions on record.

What these totals cover: FDA records filed under the name "Procaps S.A." and its spelling variant "Procaps". Records filed under related names are not included; see Related names.

Latest inspection: Apr 28, 2023 · NAI

Newer recall under related name Procaps S.A. De C.V: May 19, 2023, F-0978-2023.

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Summary

Record counts and when each FDA source was last refreshed
Records	Count	Last refreshed	Source as of	Status
Recalls	0	Nov 8, 2026	File dated Nov 3, 2026	Current
510(k) clearances	0	Nov 8, 2026	File dated Nov 2, 2026	Current
Inspections	5	Nov 13, 2026	Newest record Nov 5, 2026	Current
Compliance actions	0	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA Record by Year

Procaps S.A.'s FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Year	Inspections	OAI	Warning letters	Recall records	Class I
2026	0	0	0	0	0
2025	0	0	0	0	0
2024	0	0	0	0	0
2023	1	0	0	0	0
2022	0	0	0	0	0
2021	0	0	0	0	0
2020	0	0	0	0	0
2019	1	0	0	0	0
2018	0	0	0	0	0
2017	0	0	0	0	0

Inspections are counted by the date they ended, warning letters by the date FDA issued them and recall records by the recall start date. FDA lists one recall record per recalled product, so one recall event can add several.

Related names

Each name below has its own page. Its counts cover only the records FDA filed under that name and are not part of the totals for Procaps S.A. above.

Name	Recalls	510(k)	Inspections	Compliance	Most recent recall
Procaps S.A. De C.V Same company group	1	0	0	0	May 19, 2023 (F-0978-2023)

Recent FDA Inspections

5 inspections from Jan 22, 2009 to Apr 28, 2023.

Date	Site	Product	Classification	FEI
Apr 28, 2023	Barranquilla, Colombia	Drugs	No Action Indicated (NAI)	3008338784
Apr 8, 2019	Barranquilla, Colombia	Food/Cosmetics	No Action Indicated (NAI)	3008338784
Oct 2, 2015	Barranquilla, Colombia	Drugs	No Action Indicated (NAI)	3008338784
Jun 22, 2012	Barranquilla, Colombia	Drugs	Voluntary Action Indicated (VAI)	3008338784
Jan 22, 2009	Barranquilla, Colombia	Drugs	Voluntary Action Indicated (VAI)	3008338784

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

FDA-Inspected Facilities

1 inspected site, newest inspection first.

Facility	Location	Inspections	Latest
FEI 3008338784	Barranquilla, Colombia	5	Apr 28, 2023

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