Argenta US Manufacturing LLC — FDA Facility Profile
Argenta US Manufacturing LLC is an FDA-registered facility (FEI 0001910953) located in Shawnee, KS, US. Registered operations: ANALYSIS; API MANUFACTURE; LABEL; MANUFACTURE; PACK. RegDataLab tracks 11 FDA inspections at this facility.
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What FDA found at this site
- Latest inspection
- Dec 15, 2023: Voluntary Action Indicated (VAI)
- Inspections on record
- 11 (10 VAI, 1 NAI)
- Last OAI inspection
- None on record
- Warning letters
- None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
- Recalls as the recalling firm
- 4, latest May 31, 2017
- Import refusals
- 2
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Dec 15, 2023 | Voluntary Action Indicated (VAI) | Procedures for sterile drug products (21 CFR 211.113(b)) |
| Dec 14, 2022 | Voluntary Action Indicated (VAI) | Procedures for sterile drug products (21 CFR 211.113(b)) Component written specification (21 CFR 211.84(d)(2)) Investigations of discrepancies, failures (21 CFR 211.192) |
| Oct 28, 2022 | Voluntary Action Indicated (VAI) | Sponsor: Monitoring (21 CFR 511.1(b)(8)(ii)) |
| Aug 1, 2019 | Voluntary Action Indicated (VAI) | Floors, walls, ceiling surfaces (21 CFR 211.42(c)(10)(i)) Retest of approved components/containers/closures (21 CFR 211.87) |
| Aug 15, 2016 | No Action Indicated (NAI) | No citations listed |
| Jul 30, 2015 | Voluntary Action Indicated (VAI) | Procedures for sterile drug products (21 CFR 211.113(b)) No written record of investigation (21 CFR 211.192) |
| Nov 1, 2013 | Voluntary Action Indicated (VAI) | SOPs not followed / documented (21 CFR 211.100(b)) Procedures for sterile drug products (21 CFR 211.113(b)) Complete test data included in records (21 CFR 211.194(a)) |
| May 21, 2013 | Voluntary Action Indicated (VAI) | Procedures not in writing, fully followed (21 CFR 211.22(d)) Training--operations, GMPs, written procedures (21 CFR 211.25(a)) Prevention of cross contamination, mix-ups (21 CFR 211.130(a)) Complete test data included in records (21 CFR 211.194(a)) and 2 more |
| Mar 8, 2012 | Voluntary Action Indicated (VAI) | Reports of Analysis (Components) (21 CFR 211.84(d)(2)) |
| Jun 10, 2010 | Voluntary Action Indicated (VAI) | Inadequate number of personnel (21 CFR 211.25(c)) SOPs not followed / documented (21 CFR 211.100(b)) Written record of investigation incomplete (21 CFR 211.192) |
Recalls
| Date | Class | Recall | Product and reason |
|---|---|---|---|
| May 31, 2017 | Class III | V-0281-2017 | BAYER Droncit (praziquantel), Feline Cestocide Tablets, 23mg tablets [50 count and 150… Affected lot numbers may contain broken or crumbling tablets. |
| May 25, 2017 | Class II | V-0276-2017 | CYDECTIN (moxidectin) Injectable Solution for Beef and Nonlactating Dairy Cattle… Lack of sterility assurance: Due to potential for bottles to leak. |
| Aug 29, 2016 | Class II | V-0008-2017 | Florfenicol Mometasone Furoate Terbinafine HCl Otic Solution Claro (15mg/mL Florfenicol… Multiple complaints for leaking tubes within the blister packing. |
| Sep 6, 2005 | Class I | V-011-6 | Baytril (enrofloxacin) 3.23% Concentrate Antimicrobial Solution, For Use in Chicken and… Product approval withdrawn by FDA. |
Facility details
- Company
- Argenta US Manufacturing LLC
- Location
- Shawnee, KS (US)
- Registration Expires
- Dec 31, 2027
- Operations
- ANALYSIS; API MANUFACTURE; LABEL; MANUFACTURE; PACK
- Source
- decrs