Neogen Corporation - Mercer Rd. FDA Inspection Record
Neogen Corporation - Mercer Rd. is an FDA-registered facility (FEI 3009631819) located in Lexington, KY, US. Registered operations: ANALYSIS; LABEL; MANUFACTURE. RegDataLab tracks 11 FDA inspections and 1 compliance action at this facility.
What FDA found at this site
- Latest inspection
- Dec 21, 2023: Voluntary Action Indicated (VAI)
- Inspections on record
- 11 (6 VAI, 5 NAI)
- Last OAI inspection
- None on record
- Warning letters
- 1 listed by FDA for this FEI, latest Jan 26, 2016
- Recalls as the recalling firm
- 5, latest Oct 8, 2024
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Dec 21, 2023 | Voluntary Action Indicated (VAI) | Cleaning / Sanitizing / Maintenance (21 CFR 211.67(a)) Procedures for non-sterile drug products (21 CFR 211.113(a)) |
| Oct 27, 2022 | No Action Indicated (NAI) | No citations listed |
| Mar 16, 2021 | Voluntary Action Indicated (VAI) | Label storage access limited to authorized personnel (21 CFR 211.122(d)) Destruction of obsolete labeling (21 CFR 211.122(e)) Written program not followed (21 CFR 211.166(a)) Complete Test Data (21 CFR 211.194(a)(4)) and 1 more |
| Jan 11, 2018 | Voluntary Action Indicated (VAI) | Procedures for non-sterile drug products (21 CFR 211.113(a)) Lab controls established, including changes (21 CFR 211.160(a)) Investigations of discrepancies, failures (21 CFR 211.192) Complete Test Data (21 CFR 211.194(a)(4)) |
| Apr 28, 2016 | Voluntary Action Indicated (VAI) | Procedures not in writing, fully followed (21 CFR 211.22(d)) Lab controls established, including changes (21 CFR 211.160(a)) Annual visual exams of drug products (21 CFR 211.170(b)) |
| Nov 17, 2014 | No Action Indicated (NAI) | No citations listed |
| May 23, 2013 | Voluntary Action Indicated (VAI) | Adequate number of batches on stability (21 CFR 211.166(b)) Review of representative number of batches (21 CFR 211.180(e)(1)) Investigations of discrepancies, failures (21 CFR 211.192) Written Procedures Not Followed (21 CFR 211.80(a)) |
| Dec 21, 2012 | Voluntary Action Indicated (VAI) | Following/documenting laboratory controls (21 CFR 211.160(a)) |
| Dec 21, 2011 | No Action Indicated (NAI) | No citations listed |
| Mar 18, 2011 | No Action Indicated (NAI) | No citations listed |
Recalls
| Date | Class | Recall | Product and reason |
|---|---|---|---|
| Oct 8, 2024 | Class II | D-0073-2025 | LICEOUT, Liquid Lice Treatment for Human Use, Contents: 1 FL. OZ. (29.6 mL) per sachet… and 1 more product CGMP violations. |
| Jul 20, 2023 | Class II | V-0019-2024 | Thyrocryn (levothyroxine sodium tablets), USP, 0.4 mg, Net Contents: [180 or 1000] tablets… and 1 more product Subpotent assay values |
| Jul 11, 2023 | Class II | V-0152-2023 | Thyrocryn (levothyroxine sodium tablets), USP, 1.0 mg, Net Contents: [180 or 1000] tablets… and 1 more product Subpotent Assay values |
| Apr 12, 2023 | Class II | V-0055-2023 | Thyrocryn (levothyroxine sodium tablets), USP, 0.2 mg, Net Contents: [180 or 1000] tablets… and 1 more product Batch BN1209211 yielded subpotent Assay values as part of ongoing stability testing at the 15-month interval. Batches BN0711221 and… |
| Sep 9, 2022 | Class II | V-0220-2022 | Thyrocryn (levothyroxine sodium tablets), USP, 0.1 mg, Net Contents: [180 or 1000] tablets… and 1 more product Product is subpotent. |
FDA record score
19 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 |
|---|---|---|---|
| Inspection classified VAI | Dec 21, 2023 | 6 x 0.6 | 3.6 |
| Class II recall D-0073-2025, this FEI as the recalling firm | Oct 8, 2024 | 4 x 0.6 | 2.4 |
| Class II recall V-0019-2024, this FEI as the recalling firm | Jul 20, 2023 | 4 x 0.6 | 2.4 |
| Class II recall V-0152-2023, this FEI as the recalling firm | Jul 11, 2023 | 4 x 0.6 | 2.4 |
| Class II recall V-0055-2023, this FEI as the recalling firm | Apr 12, 2023 | 4 x 0.6 | 2.4 |
| Class II recall V-0220-2022, this FEI as the recalling firm | Sep 9, 2022 | 4 x 0.6 | 2.4 |
| Inspection classified VAI | Mar 16, 2021 | 6 x 0.25 | 1.5 |
| Inspection classified VAI | Jan 11, 2018 | 6 x 0.25 | 1.5 |
| Inspection classified VAI | Apr 28, 2016 | 10 years or older, so it adds no points | 0 |
| Warning letter on FDA's dashboard, which does not show close-outs | Jan 26, 2016 | 10 years or older, so it adds no points | 0 |
| Inspection classified VAI | May 23, 2013 | 10 years or older, so it adds no points | 0 |
| Inspection classified VAI | Dec 21, 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
- Neogen Corporation
- Location
- Lexington, KY (US)
- Registration Expires
- Dec 31, 2027
- Operations
- ANALYSIS; LABEL; MANUFACTURE
- Source
- decrs