Phibro Animal Health Corporation FDA Inspection Record
Phibro Animal Health Corporation is an FDA-inspected facility (FEI 1000122177) located in Teaneck, NJ, US. RegDataLab tracks 2 FDA inspections at this facility.
What FDA found at this site
- Latest inspection
- Feb 25, 2015: Voluntary Action Indicated (VAI)
- Inspections on record
- 2 (2 VAI)
- 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
- 10, latest Jul 13, 2018
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Feb 25, 2015 | Voluntary Action Indicated (VAI) | Components uniformly dispersed and stable (21 CFR 226.58(d)) |
| Oct 25, 2012 | Voluntary Action Indicated (VAI) | No citations listed |
Recalls
| Date | Class | Recall | Product and reason |
|---|---|---|---|
| Jul 13, 2018 | Class II | V-0136-2019 | Phibro Nicarb (nicarbazin) 25% Type A Medicated Article, Net Wt 50 lb (22.68 kg)… Nicarb 25% Type A medicated article tested at 24.2% (Nicarbazin) below the potency specification of 24.5-26.5 % at the 12 month stability… |
| Jun 27, 2018 | Class II | V-0137-2019 | Phibro Nicarb 25% Type A Medicated Article Net Wt 50 lb (22.68 kg) Distributed by: Phibro… Nicarb 25% Type A Medicated Article lot F72510108KA is under recall because the 9-month stability sample has a confirmed out of… |
| Feb 6, 2018 | Class II | V-0249-2018 | Phibro Nicarb 25% (nicarbazin) Type A Medicated Article
Net Wt 50 lb… The 18-month and 12-month stability samples have confirmed out of specification (OOS), results of 24.4% and 24.2% respectively for two… |
| Apr 6, 2017 | Class II | V-0111-2017 | Nicarb 25% Type A Medicated Article 8.4 mg/kg
Distributed by : Phibrio Animal Health… Phibro Animal Health Corporation (Phibro) is initiating this recall because the 18-month stability sample (kept under the VICH 25¿C/60%RH… |
| Jan 9, 2017 | Class II | V-0084-2017 | NeoTerramycin 100/100D Type A Medicated Article
Net Wt. 50 lbs. (22.7 kg)
Phibro Animal… NeoTerramycin 100/100D Type A Medicated Article, LOT NUMBER A61370001NK was confirmed Out of Specification (OOS) for the neomycin… |
| May 26, 2016 | Class II | V-0006-2017 | Neo-Terramycin 100/100D (neomycin-oxytetracycline), Type A Medicated Article Antibiotic… Out of Specification for Neo Terramycin 100/100 D Type A Medicated Article. |
| Jan 13, 2016 | Class II | V-489-2016 | Phibro Animal Health Corporation
NeoTerramycin 100/100D Type A Medicated Article
Net… This recall was initiated because NeoTerramycin (100/100D lot number A41770017NK tested below (88.5 g/lb) the potency specification of… |
| Sep 8, 2015 | Class II | V-486-2016 | Stafac 50 Type A Medicated Articles
NDC# 66104-8815
Packed in a 50 lb/bag (22.6 kg/bag)… This recall was initiated because Stafac 50 lot number R40430001VA tested below (41.7 g/lb) the potency specification of (42.5 - 57.5 g/lb)… |
| Apr 22, 2015 | Class II | V-0037-2017 | Stafac 20 Type A Medicated Article
20 g/Ib equivalent to 44 g/KG
NDC… Stafac 20 lot numbers N32704049VW and N32764167VW tested below the potency specification of 17.0-23.0 g/lb at the 18 month stability… |
| Feb 27, 2015 | Class II | V-251-2015 | V-Max 50 Type A Medicated Article # 66104-9601
Packed in a 50 lb Multi-wall bag, with… This recall has been initiated because Vmax 50 lot N30360585VN tested below (41.4 g/lb) the potency specification of 42.5 57.5 g/lb at the… |
FDA record score
5 of 100. A count of this site's adverse public FDA records, weighted by how recent each one is. A higher number means more, or more recent, records. Each record below adds the points shown.
12 records behind this number
| Record | Date | Points x age weight | Adds |
|---|---|---|---|
| Class II recall V-0136-2019, this FEI as the recalling firm | Jul 13, 2018 | 4 x 0.25 | 1 |
| Class II recall V-0137-2019, this FEI as the recalling firm | Jun 27, 2018 | 4 x 0.25 | 1 |
| Class II recall V-0249-2018, this FEI as the recalling firm | Feb 6, 2018 | 4 x 0.25 | 1 |
| Class II recall V-0111-2017, this FEI as the recalling firm | Apr 6, 2017 | 4 x 0.25 | 1 |
| Class II recall V-0084-2017, this FEI as the recalling firm | Jan 9, 2017 | 4 x 0.25 | 1 |
| Class II recall V-0006-2017, this FEI as the recalling firm | May 26, 2016 | 10 years or older, so it adds no points | 0 |
| Class II recall V-489-2016, this FEI as the recalling firm | Jan 13, 2016 | 10 years or older, so it adds no points | 0 |
| Class II recall V-486-2016, this FEI as the recalling firm | Sep 8, 2015 | 10 years or older, so it adds no points | 0 |
| Class II recall V-0037-2017, this FEI as the recalling firm | Apr 22, 2015 | 10 years or older, so it adds no points | 0 |
| Class II recall V-251-2015, this FEI as the recalling firm | Feb 27, 2015 | 10 years or older, so it adds no points | 0 |
| Inspection classified VAI | Feb 25, 2015 | 10 years or older, so it adds no points | 0 |
| Inspection classified VAI | Oct 25, 2012 | 10 years or older, so it adds no points | 0 |
When each source was last refreshed
| Records | Last refreshed | Source as of | Status |
|---|---|---|---|
| Inspections | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Inspection citations | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions (warning letters, injunctions and other action types) | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
| Warning letter text | Nov 14, 2026 | Newest record Nov 10, 2026 | Current |
| Recalls (Enforcement Report) | Nov 14, 2026 | Newest record Nov 11, 2026 | Current |
| Form 483s and inspection documents | Nov 13, 2026 | Newest record Nov 12, 2026 | Current |
| Import refusals | Nov 2, 2026 | Newest record Oct 22, 2026 | Current |
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Facility details
- Company
- Phibro Animal Health Corporation
- Location
- Teaneck, NJ (US)
- Source
- inspections