Teva Branded Pharmaceutical Products R & D, Inc. FDA Inspection Record
Teva Branded Pharmaceutical Products R & D, Inc. is an FDA-inspected facility (FEI 1000140211) located in Miami, FL, US. RegDataLab tracks 1 FDA inspection at this facility.
What FDA found at this site
- Latest inspection
- Jan 27, 2011: No Action Indicated (NAI)
- Inspections on record
- 1 (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
- 7, latest Jun 13, 2008
- Import refusals
- 2
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Jan 27, 2011 | No Action Indicated (NAI) | No citations listed |
Recalls
| Date | Class | Recall | Product and reason |
|---|---|---|---|
| Jun 13, 2008 | Class II | D-361-2008 | B-Plex Tablets, Multi-vitamin tablets, 100 tablets bottle, Rx only, Mfr. By: Goldline… and 2 more products cGMP Deviations; Lack of stability indicating methods by mfr |
| Mar 12, 2008 | Class III | D-182-2008 | Cromolyn Sodium Inhalation Solution USP 20 mg/2 mL Unit Dose Vials, 60 and 120 count… Failed pH Specification |
| Nov 13, 2007 | Class III | D-064-2008 | Lisinopril Tablets USP, 2.5 mg, 500-tablet bottles, Rx only, NDC 0172-3757-70… The product failed to meet assay specification. |
| Nov 9, 2007 | Class III | D-063-2008 | Aspirin Tablets, 81 mg, enteric coated, 100-tablet unit dose package, OTC, NDC… Product fails assay and impurity specification. |
| Nov 8, 2007 | Class III | D-073-2008 | Capsicum Oleoresin, containing Capsaicin 0.025%, Topical Analgesic Cream, Net Wt 2 oz (57… Subpotent (by manufacturer Sheffield) |
| Aug 10, 2007 | Class III | D-970-2007 | Product is labeled as Goldline Genebs Extra Strength Caplets 500 mg Pain Reliever/Fever… Foreign capsule found in a 1000 count bottle of Acetaminophen (APAP) 500 mg. |
| Apr 6, 2007 | Class III | D-799-2007 | Oxybutynin Chloride Tablets, 5mg, 100 tablet bottles, Rx only, NDC 0182-1289-89… The product does not meet dissolution specifications. |
FDA record score
0 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.
1 record behind this number
| Record | Date | Points x age weight | Adds |
|---|---|---|---|
| Class II recall D-361-2008, this FEI as the recalling firm | Jun 13, 2008 | 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
- Teva Branded Pharmaceutical Products R&D, Inc
- Location
- Miami, FL (US)
- Source
- inspections