Ascend Laboratories, LLC — FDA Facility Profile
Ascend Laboratories, LLC is an FDA-inspected facility (FEI 3004459274) located in Bedminster, NJ, US. RegDataLab tracks 5 FDA inspections and 2 compliance actions at this facility.
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What FDA found at this site
- Latest inspection
- Nov 10, 2021: Voluntary Action Indicated (VAI)
- Inspections on record
- 5 (1 OAI, 2 VAI, 2 NAI)
- Last OAI inspection
- Dec 11, 2013
- 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
- 38, latest Oct 6, 2026
- Import refusals
- 1
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Nov 10, 2021 | Voluntary Action Indicated (VAI) | Failure to develop written procedures (21 CFR 314.80(b)) Late submission of annual safety reports (21 CFR 314.80(c)(2)) Timely submission (21 CFR 314.81(b)(2)) |
| Jun 24, 2021 | Voluntary Action Indicated (VAI) | Procedures not in writing, fully followed (21 CFR 211.22(d)) Investigations of discrepancies, failures (21 CFR 211.192) |
| Jul 6, 2017 | No Action Indicated (NAI) | No citations listed |
| Dec 11, 2013 | Official Action Indicated (OAI) | Procedures not in writing, fully followed (21 CFR 211.22(d)) Training--operations, GMPs, written procedures (21 CFR 211.25(a)) Recall facilitation (21 CFR 211.150(b)) Procedures to be written and followed (21 CFR 211.198(a)) |
| Feb 10, 2011 | No Action Indicated (NAI) | No citations listed |
Recalls
| Date | Class | Recall | Product and reason |
|---|---|---|---|
| Oct 6, 2026 | Class II | D-0045-2027 | Amlodipine and Olmesartan Medoxomil Tablets, 10mg/40mg, 30 Tablets, Rx only, Manufactured… Out of specification due to dissolution. |
| Jul 16, 2026 | Class III | D-0737-2026 | Dabigatran Etexilate Capsules, 150 mg, 60-count (6x10) blister pack further packaged in a… and 2 more products Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and… |
| Jul 8, 2026 | Class II | D-0712-2026 | Amlodipine and Olmesartan Medoxomil Tablets, 10 mg/20 mg, 30 Tablets per bottle, Rx Only… Failed Dissolution Specifications; Olmesartan Medoxomil content below specifications |
| Jun 30, 2026 | Class III | D-0735-2026 | Dabigatran etexilate Capsules, 110 mg, 60-count carton (6x10), Rx Only, Manufactured by… and 1 more product Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity… |
| Jun 1, 2026 | Class II | D-0597-2026 | Minocycline Hydrochloride Extended-Release Tablets, USP, 115 mg, 30-count bottle, Rx Only… Failed Dissolution Specifications: An out-of-specification (OOS) result was observed during the 9th month of dissolution test analysis |
| May 5, 2026 | Class II | D-0556-2026 | Amlodipine and Olmesartan Medoxomil Tablets, 5mg/40mg, Rx Only, 30-count bottle… Failed Dissolution Specifications: Olmesartan Medoxomil content below specifications |
| Apr 27, 2026 | Class II | D-0547-2026 | Ascend Laboratories, LLC, Metoprolol Succinate Extended-Release Tablets, USP, 25 mg* Rx… Failed Dissolution Specifications |
| Sep 19, 2025 | Class II | D-0017-2026 | Atorvastatin Calcium Tablets USP, 10 mg, Rx Only a) 90-count bottle (NDC 67877-511-90)… and 3 more products Failed Dissolution Specifications |
| Aug 28, 2025 | Class II | D-0645-2025 | Aripiprazole Tablets, USP, 10 mg, 30-count bottles, Rx only, Manufactured by: Alken… Superpotent drug |
| Jul 21, 2025 | Class II | D-0576-2025 | Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/ 40 mg, 30-count bottle, Rx Only… Failed Dissolution Specifications: low dissolution results |
Facility details
- Company
- Ascend Laboratories, LLC
- Location
- Bedminster, NJ (US)
- Source
- inspections