Recent regulatory events
Records dated in the 12 months to 16 Oct 2026 for the sites in this directory, newest first. Dates are the regulator's event date (inspection end date, action date, recall initiation date, issue date), not the date FDA or EMA published them, so older events can appear after each refresh.
- 18 Sep 2026Warning letter Curia — Rensselaer, United States: FDA warning letter (Drugs)
Source: FDA warning letter (fda.gov) (FEI 1310298, case 728790)
- 21 Jul 2026FDA inspection Curia — Aurangabad, India: FDA inspection classified VAI
Source: FDA Data Dashboard – Inspections (FEI 3008580576, inspection ID 1330244)
- 16 Jul 2026Form 483 observations Solvias — Canton, United States: 1 posted Form 483 citation(s)
Source: FDA Data Dashboard – Citations (FEI 3001551778, inspection ID 1326666)
- 16 Jul 2026FDA inspection Solvias — Canton, United States: FDA inspection classified VAI
Source: FDA Data Dashboard – Inspections (FEI 3001551778, inspection ID 1326666)
- 07 Jul 2026FDA inspection Thermo Fisher Scientific (Patheon) — Swindon, United Kingdom: FDA inspection classified VAI
Source: FDA Data Dashboard – Inspections (FEI 3002807216, inspection ID 1324282)
- 30 Jun 2026FDA inspection Thermo Fisher Scientific (Patheon) — Greenville, United States: FDA inspection classified NAI
Source: FDA Data Dashboard – Inspections (FEI 1018495, inspection ID 1329462)
- 18 Jun 2026FDA inspection Frontage Laboratories — Exton, United States: FDA inspection classified VAI
Source: FDA Data Dashboard – Inspections (FEI 3006799640, inspection ID 1330228)
- 12 Jun 2026FDA inspection Thermo Fisher Scientific (Patheon) — Florence, United States: FDA inspection classified NAI
Source: FDA Data Dashboard – Inspections (FEI 3000717636, inspection ID 1323514)
- 29 May 2026Form 483 observations Pace Life Sciences — Oakdale, United States: 2 posted Form 483 citation(s)
Source: FDA Data Dashboard – Citations (FEI 3001452367, inspection ID 1319822)
- 29 May 2026FDA inspection AGC Biologics — Bothell, United States: FDA inspection classified NAI
Source: FDA Data Dashboard – Inspections (FEI 3000209996, inspection ID 1303206)
- 29 May 2026FDA inspection Pace Life Sciences — Oakdale, United States: FDA inspection classified VAI
Source: FDA Data Dashboard – Inspections (FEI 3001452367, inspection ID 1319822)
- 22 May 2026Form 483 observations Catalent — Morrisville, United States: 1 posted Form 483 citation(s)
Source: FDA Data Dashboard – Citations (FEI 1000110912, inspection ID 1303072)
- 22 May 2026FDA inspection Catalent — Morrisville, United States: FDA inspection classified VAI
Source: FDA Data Dashboard – Inspections (FEI 1000110912, inspection ID 1303072)
- 20 May 2026FDA inspection Bachem — Vista, United States: FDA inspection classified VAI
Source: FDA Data Dashboard – Inspections (FEI 3000718309, inspection ID 1318910)
- 19 May 2026Form 483 observations Lonza — Bend, United States: 1 posted Form 483 citation(s)
Source: FDA Data Dashboard – Citations (FEI 3003722743, inspection ID 1317820)
- 19 May 2026Form 483 observations Lonza — Bend, United States: 1 posted Form 483 citation(s)
Source: FDA Data Dashboard – Citations (FEI 1000656789, inspection ID 1317818)
- 19 May 2026FDA inspection Lonza — Bend, United States: FDA inspection classified VAI
Source: FDA Data Dashboard – Inspections (FEI 1000656789, inspection ID 1317818)
- 19 May 2026FDA inspection Lonza — Bend, United States: FDA inspection classified VAI
Source: FDA Data Dashboard – Inspections (FEI 3003722743, inspection ID 1317820)
- 15 May 2026Form 483 observations Unither Pharmaceuticals — Rochester, United States: 9 posted Form 483 citation(s)
Source: FDA Data Dashboard – Citations (FEI 1314625, inspection ID 1320018)
- 15 May 2026FDA inspection Unither Pharmaceuticals — Rochester, United States: FDA inspection classified OAI
Source: FDA Data Dashboard – Inspections (FEI 1314625, inspection ID 1320018)
- 04 May 2026FDA inspection Bachem — Torrance, United States: FDA inspection classified VAI
Source: FDA Data Dashboard – Inspections (FEI 2024023, inspection ID 1315898)
- 01 May 2026FDA inspection PPD (Thermo Fisher Scientific) — Middleton, United States: FDA inspection classified NAI
Source: FDA Data Dashboard – Inspections (FEI 2129896, inspection ID 1320960)
- 22 Apr 2026Form 483 observations Alcami — Charleston, United States: 7 posted Form 483 citation(s)
Source: FDA Data Dashboard – Citations (FEI 1000110990, inspection ID 1313488)
- 22 Apr 2026FDA inspection Alcami — Charleston, United States: FDA inspection classified VAI
Source: FDA Data Dashboard – Inspections (FEI 1000110990, inspection ID 1313488)
- 22 Apr 2026FDA inspection Sharp Services — Allentown, United States: FDA inspection classified NAI
Source: FDA Data Dashboard – Inspections (FEI 3004161147, inspection ID 1314200)
- 14 Apr 2026Form 483 observations Frontage Laboratories — Exton, United States: 4 posted Form 483 citation(s)
Source: FDA Data Dashboard – Citations (FEI 3006799640, inspection ID 1312304)
- 14 Apr 2026FDA inspection Frontage Laboratories — Exton, United States: FDA inspection classified VAI
Source: FDA Data Dashboard – Inspections (FEI 3006799640, inspection ID 1312304)
- 01 Apr 2026FDA inspection KBI Biopharma — Durham, United States: FDA inspection classified VAI
Source: FDA Data Dashboard – Inspections (FEI 3004638264, inspection ID 1312108)
- 03 Mar 2026Warning letter Simtra BioPharma Solutions — Halle (Westf.), Germany: FDA warning letter (Drugs)
Source: FDA warning letter (fda.gov) (FEI 3002806419, case 720436)
- 10 Feb 2026Form 483 observations Thermo Fisher Scientific (Patheon) — Monza, Italy: 1 posted Form 483 citation(s)
Source: FDA Data Dashboard – Citations (FEI 3003065803, inspection ID 1304236)
- 10 Feb 2026FDA inspection Thermo Fisher Scientific (Patheon) — Monza, Italy: FDA inspection classified VAI
Source: FDA Data Dashboard – Inspections (FEI 3003065803, inspection ID 1304236)
- 06 Feb 2026Form 483 observations Alcami — Charleston, United States: 6 posted Form 483 citation(s)
Source: FDA Data Dashboard – Citations (FEI 1000110990, inspection ID 1301852)
- 06 Feb 2026FDA inspection Lonza — Portsmouth, United States: FDA inspection classified VAI
Source: FDA Data Dashboard – Inspections (FEI 3001451441, inspection ID 1304046)
- 06 Feb 2026FDA inspection Sharp Services — Conshohocken, United States: FDA inspection classified NAI
Source: FDA Data Dashboard – Inspections (FEI 2518332, inspection ID 1303654)
- 06 Feb 2026FDA inspection Alcami — Charleston, United States: FDA inspection classified VAI
Source: FDA Data Dashboard – Inspections (FEI 1000110990, inspection ID 1301852)
- 05 Feb 2026FDA inspection Curia — Rensselaer, United States: FDA inspection classified OAI
Source: FDA Data Dashboard – Inspections (FEI 1310298, inspection ID 1305832)
- 30 Jan 2026FDA inspection Thermo Fisher Scientific (Patheon) — Ferentino, Italy: FDA inspection classified NAI
Source: FDA Data Dashboard – Inspections (FEI 3004110157, inspection ID 1306942)
- 30 Jan 2026FDA inspection Catalent — Saint Petersburg, United States: FDA inspection classified VAI
Source: FDA Data Dashboard – Inspections (FEI 1811396, inspection ID 1282788)
- 16 Jan 2026FDA inspection Olon — Casaletto Lodigiano, Italy: FDA inspection classified VAI
Source: FDA Data Dashboard – Inspections (FEI 3002808159, inspection ID 1321568)
- 17 Dec 2025FDA inspection Catalent — Philadelphia, United States: FDA inspection classified NAI
Source: FDA Data Dashboard – Inspections (FEI 3007617094, inspection ID 1297392)
- 12 Dec 2025FDA inspection Hovione — Taipa, Macao: FDA inspection classified VAI
Source: FDA Data Dashboard – Inspections (FEI 3002807210, inspection ID 1298568)
- 10 Dec 2025Form 483 observations Piramal Pharma Solutions — Lexington, United States: 4 posted Form 483 citation(s)
Source: FDA Data Dashboard – Citations (FEI 3006419237, inspection ID 1295282)
- 10 Dec 2025FDA inspection Piramal Pharma Solutions — Lexington, United States: FDA inspection classified VAI
Source: FDA Data Dashboard – Inspections (FEI 3006419237, inspection ID 1295282)
- 02 Dec 2025FDA inspection Curia — Springfield, United States: FDA inspection classified NAI
Source: FDA Data Dashboard – Inspections (FEI 1941037, inspection ID 1294960)
- 27 Nov 2025FDA inspection Curia — Bon Encontre, France: FDA inspection classified VAI
Source: FDA Data Dashboard – Inspections (FEI 3009615607, inspection ID 1332770)
- 21 Nov 2025FDA inspection Sharp Services — Allentown, United States: FDA inspection classified NAI
Source: FDA Data Dashboard – Inspections (FEI 3004161147, inspection ID 1283904)
- 14 Nov 2025FDA inspection CARBOGEN AMCIS — Bubendorf, Switzerland: FDA inspection classified VAI
Source: FDA Data Dashboard – Inspections (FEI 3000998501, inspection ID 1327698)
- 13 Nov 2025Form 483 observations Kindeva Drug Delivery — Northridge, United States: 2 posted Form 483 citation(s)
Source: FDA Data Dashboard – Citations (FEI 2010441, inspection ID 1286864)
- 13 Nov 2025FDA inspection Kindeva Drug Delivery — Northridge, United States: FDA inspection classified VAI
Source: FDA Data Dashboard – Inspections (FEI 2010441, inspection ID 1286864)
- 04 Nov 2025Form 483 observations Grand River Aseptic Manufacturing — Grand Rapids, United States: 2 posted Form 483 citation(s)
Source: FDA Data Dashboard – Citations (FEI 3008716173, inspection ID 1293364)
- 04 Nov 2025FDA inspection Grand River Aseptic Manufacturing — Grand Rapids, United States: FDA inspection classified VAI
Source: FDA Data Dashboard – Inspections (FEI 3008716173, inspection ID 1293364)
- 24 Oct 2025Form 483 observations Catalent — Greenville, United States: 3 posted Form 483 citation(s)
Source: FDA Data Dashboard – Citations (FEI 3000209735, inspection ID 1267356)
- 24 Oct 2025FDA inspection Catalent — Greenville, United States: FDA inspection classified VAI
Source: FDA Data Dashboard – Inspections (FEI 3000209735, inspection ID 1267356)
Subscribe via RSS.