Par Formulations Private Limited

FDA Regulatory Profile

Par Formulations Private Limited has 1 FDA recall, 9 inspections, 0 510(k) clearances and 0 compliance actions on record.

What these totals cover: FDA records filed under the name "Par Formulations Private Limited".

Latest recall
D-0061-2023 · Class II · Nov 10, 2022
Latest inspection
Jun 10, 2026 · VAI

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls1Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections9Nov 13, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

FDA record by year

Par Formulations Private Limited's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Par Formulations Private Limited: FDA inspections per year 2017: 0 inspections020172018: 0 inspections020182019: 1 inspections120192020: 0 inspections020202021: 0 inspections020212022: 0 inspections020222023: 3 inspections320232024: 0 inspections020242025: 0 inspections020252026: 1 inspections12026
YearInspectionsOAIWarning lettersRecall recordsClass I
202610000
202500000
202400000
202330000
202200010
202100000
202000000
201910000
201800000
201700000

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 recalls

1 recall record on Nov 10, 2022.

NumberClassProductDate
D-0061-2023Class IIPhenoxybenzamine Hydrochloride Capsules, USP 10mg, 100-count bottles, RX only Dist. by: Par…Nov 10, 2022

Recent FDA inspections

9 inspections from Sep 21, 2011 to Jun 10, 2026.

DateSiteProductClassificationFEI
Jun 10, 2026Chennai, IndiaDrugsVoluntary Action Indicated (VAI)3007027193
Dec 8, 2023Navi Mumbai, IndiaDrugsVoluntary Action Indicated (VAI)3014425346
May 12, 2023Indore, IndiaDrugsNo Action Indicated (NAI)3016268582
Mar 24, 2023Chennai, IndiaDrugsNo Action Indicated (NAI)3007027193
Jun 21, 2019Chennai, IndiaDrugsNo Action Indicated (NAI)3007027193
Dec 7, 2016Chennai, IndiaDrugsVoluntary Action Indicated (VAI)3007027193
Apr 17, 2015Chennai, IndiaDrugsNo Action Indicated (NAI)3007027193
Oct 17, 2013Chennai, IndiaDrugsNo Action Indicated (NAI)3007027193
Sep 21, 2011Chennai, IndiaDrugsNo Action Indicated (NAI)3007027193
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.

FacilityLocationInspectionsLatest
FEI 3007027193Chennai, India7Jun 10, 2026
FEI 3014425346Navi Mumbai, India1Dec 8, 2023
FEI 3016268582Indore, India1May 12, 2023

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