Phibro Animal Health Corporation FDA Inspection Record
Phibro Animal Health Corporation is an FDA-inspected facility (FEI 1150033) located in Salisbury, MD, US. RegDataLab tracks 7 FDA inspections at this facility.
What FDA found at this site
- Latest inspection
- Nov 17, 2023: Voluntary Action Indicated (VAI)
- Inspections on record
- 7 (5 VAI, 2 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
- 3, latest Jul 18, 2019
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Nov 17, 2023 | Voluntary Action Indicated (VAI) | Appropriate action not taken (21 CFR 226.115) Components receiving, testing, handling, et. al. (21 CFR 226.42(a)) |
| Jan 10, 2020 | Voluntary Action Indicated (VAI) | Components receiving, testing, handling, et. al. (21 CFR 226.42(a)) |
| Apr 13, 2017 | Voluntary Action Indicated (VAI) | No citations listed |
| Sep 18, 2015 | Voluntary Action Indicated (VAI) | No citations listed |
| Apr 10, 2013 | No Action Indicated (NAI) | No citations listed |
| Apr 13, 2011 | Voluntary Action Indicated (VAI) | Lot number on label (21 CFR 226.80(a)(4)) |
| Nov 19, 2008 | No Action Indicated (NAI) | No citations listed |
Recalls
| Date | Class | Recall | Product and reason |
|---|---|---|---|
| Jul 18, 2019 | Class III | V-0228-2019 | Zoamix Type A Medicated Article, exp. date 01/2021 Subject lot was released prior to approval. |
| May 3, 2018 | Class II | V-0126-2019 | Bovatec 91, Type A Medicated Article, packaged in 50 lbs, polyethylene lined kraft paper… Product is being recalled due to the distribution of an unreleased lot. |
| Sep 22, 2011 | Class II | V-002-2012 | Bovatec 91 Brand of Lasalocid Sodium Type A Medicated Article The product failed to meet potency specifications during stability testing. |
FDA record score
8 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.
7 records behind this number
| Record | Date | Points x age weight | Adds |
|---|---|---|---|
| Inspection classified VAI | Nov 17, 2023 | 6 x 0.6 | 3.6 |
| Inspection classified VAI | Jan 10, 2020 | 6 x 0.25 | 1.5 |
| Inspection classified VAI | Apr 13, 2017 | 6 x 0.25 | 1.5 |
| Class II recall V-0126-2019, this FEI as the recalling firm | May 3, 2018 | 4 x 0.25 | 1 |
| Inspection classified VAI | Sep 18, 2015 | 10 years or older, so it adds no points | 0 |
| Class II recall V-002-2012, this FEI as the recalling firm | Sep 22, 2011 | 10 years or older, so it adds no points | 0 |
| Inspection classified VAI | Apr 13, 2011 | 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
- Salisbury, MD (US)
- Source
- inspections