MeriCal LLC FDA Inspection Record
MeriCal LLC is an FDA-registered facility (FEI 3001574462) located in Orange, CA, US. Registered operations: MANUFACTURE. RegDataLab tracks 5 FDA inspections at this facility.
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What FDA found at this site
- Latest inspection
- Apr 30, 2025: Voluntary Action Indicated (VAI)
- Inspections on record
- 5 (3 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 Jan 9, 2020
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Apr 30, 2025 | Voluntary Action Indicated (VAI) | Representative Samples (21 CFR 211.84(b)) Calculations performed are in the records (21 CFR 211.194(a)(5)) |
| Dec 19, 2024 | Voluntary Action Indicated (VAI) | Quality control - reject; specification not met (21 CFR 111.113(b)(2)) Hygienic practices (21 CFR 111.10(b)) Equipment - design - appropriate and suitable (21 CFR 111.27(a)) Specifications - components (21 CFR 111.70(b)) and 4 more |
| Feb 13, 2019 | No Action Indicated (NAI) | No citations listed |
| Nov 20, 2017 | Voluntary Action Indicated (VAI) | Master manufacturing record - sampling, tests, examinations (21 CFR 111.210(h)(2)) Specifications met - verify; finished batch (21 CFR 111.75(c)) |
| Feb 27, 2013 | No Action Indicated (NAI) | No citations listed |
Recalls
| Date | Class | Recall | Product and reason |
|---|---|---|---|
| Jan 9, 2020 | Class II | F-0631-2020 | Meijer Joint Health
Triple Strength Formula Glucosamine Hydrochloride 1500 mg;
Helps… and 1 more product Product label does not contain Crustacean Shellfish on the ingredient list or allergen information |
| Oct 31, 2019 | Class III | F-0193-2020 | Leader Advanced Probiotic with 6 Probiotic Strains and 20 billion Live Cultures.
30… Incorrect Probiotic blend indicated in the Supplemental Facts Panel on product label. |
| Mar 19, 2019 | Class III | F-1275-2019 | Walgreens Probiotic 12.5 Billion Active Cultures, 30 capsules;
Dietary… Incorrect probiotic strain used in formulation which did not match product labeling. |
Facility details
- Company
- MeriCal LLC
- Location
- Orange, CA (US)
- Registration Expires
- Dec 31, 2026
- Operations
- MANUFACTURE
- Source
- decrs