FDA Inspection 1277530 - Chartwell Pharmaceuticals LLC - November 18, 2025

FDA Inspection 1277530 for Chartwell Pharmaceuticals LLC on November 18, 2025. Classification: Official Action Indicated (OAI).

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Record Summary

FDA Inspection 1277530 for Chartwell Pharmaceuticals LLC on November 18, 2025. Classification: Official Action Indicated (OAI).

Violation Codes

21 CFR 211.100(a)

21 CFR 211.101(b)

21 CFR 211.160(a)

21 CFR 211.160(b)(2)

21 CFR 211.166(a)

21 CFR 211.180(e)(1)

21 CFR 211.188

21 CFR 211.192

21 CFR 211.204

21 CFR 211.22(d)

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Record Information

Company

Chartwell Pharmaceuticals LLC

Inspection Date

November 18, 2025

Product Type

Drugs

ID: 67001a8a-eaff-41fe-8ba4-053955d4a776

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