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PCAS

FDA Regulatory Profile

PCAS has 0 FDA recalls, 16 inspections, 0 510(k) clearances and 0 compliance actions on record.

What these totals cover: FDA records filed under the name "PCAS".

Latest inspection: Apr 25, 2025 · VAI

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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	16	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

PCAS'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	1	0	0	0	0
2024	0	0	0	0	0
2023	0	0	0	0	0
2022	2	0	0	0	0
2021	1	0	0	0	0
2020	0	0	0	0	0
2019	2	0	0	0	0
2018	2	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.

Recent FDA inspections

16 inspections from Jun 25, 2009 to Apr 25, 2025.

Date	Site	Product	Classification	FEI
Apr 25, 2025	Limay, France	Drugs	Voluntary Action Indicated (VAI)	3002808156
Mar 31, 2022	Limay, France	Drugs	Voluntary Action Indicated (VAI)	3002808156
Mar 17, 2022	Villeneuve-La-Garenne, France	Drugs	Voluntary Action Indicated (VAI)	3004704673
Mar 19, 2021	Aramon, France	Drugs	Voluntary Action Indicated (VAI)	3003623331
Mar 7, 2019	Limay, France	Drugs	Voluntary Action Indicated (VAI)	3002808156
Feb 28, 2019	Villeneuve-La-Garenne, France	Drugs	Voluntary Action Indicated (VAI)	3004704673
Sep 14, 2018	Aramon, France	Drugs	No Action Indicated (NAI)	3003623331
Sep 7, 2018	Limay, France	Drugs	Voluntary Action Indicated (VAI)	3002808156
Oct 21, 2016	Villeneuve-La-Garenne, France	Drugs	No Action Indicated (NAI)	3004704673
Sep 23, 2016	Aramon, France	Drugs	No Action Indicated (NAI)	3003623331
Apr 29, 2016	Limay, France	Drugs	Voluntary Action Indicated (VAI)	3002808156
Jun 27, 2013	Limay, France	Drugs	Voluntary Action Indicated (VAI)	3002808156
May 29, 2013	Aramon, France	Drugs	No Action Indicated (NAI)	3003623331
Feb 16, 2012	Villeneuve-La-Garenne, France	Drugs	No Action Indicated (NAI)	3004704673
Oct 22, 2009	Limay, France	Drugs	Voluntary Action Indicated (VAI)	3002808156
Jun 25, 2009	Aramon, France	Drugs	Voluntary Action Indicated (VAI)	3003623331

NAI: No objectionable conditions or practices were found during the inspection.
VAI: Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
OAI: 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

3 inspected sites, newest inspection first.

Facility	Location	Inspections	Latest
FEI 3002808156	Limay, France	7	Apr 25, 2025
FEI 3004704673	Villeneuve-La-Garenne, France	4	Mar 17, 2022
FEI 3003623331	Aramon, France	5	Mar 19, 2021

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