Neogen Culture Media FDA Inspection Record
Neogen Culture Media is an FDA-registered facility (FEI 1120041) located in LANSING, MI, US. RegDataLab tracks 4 FDA inspections and 1 compliance action at this facility.
What FDA found at this site
- Latest inspection
- Apr 7, 2025: No Action Indicated (NAI)
- Inspections on record
- 4 (2 VAI, 2 NAI)
- Last OAI inspection
- None on record
- Warning letters
- 1 listed by FDA for this FEI, latest Sep 24, 2026
- Recalls as the recalling firm
- 10, latest Oct 23, 2026
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Apr 7, 2025 | No Action Indicated (NAI) | Design changes - Lack of or Inadequate Procedures (21 CFR 820.30(i)) Lack/Inad procedure-Monitoring/Control of Validated Proces (21 CFR 820.75(b)) Lack of or inadequate procedures (21 CFR 820.100(a)) Lack of or inadequate DHR procedures (21 CFR 820.184) and 4 more |
| Oct 7, 2016 | Voluntary Action Indicated (VAI) | Lack/Inad procedure-Monitoring/Control of Validated Proces (21 CFR 820.75(b)) Lack of or inadequate procedures (21 CFR 820.100(a)) Lack of or inadequate organizational structure (21 CFR 820.20(b)) Report of risk to health (21 CFR 806.10(a)(1)) and 1 more |
| Apr 11, 2014 | No Action Indicated (NAI) | Lack of or inadequate complaint procedures (21 CFR 820.198(a)) Procedures not adequately established or maintained (21 CFR 820.40) Design validation- Lack of or inadequate procedures (21 CFR 820.30(g)) Lack/Inad procedure-Monitoring/Control of Validated Proces (21 CFR 820.75(b)) and 3 more |
| Jan 9, 2012 | Voluntary Action Indicated (VAI) | Procedures not adequately established or maintained (21 CFR 820.40) Design changes - Lack of or Inadequate Procedures (21 CFR 820.30(i)) Lack of or inadequate procedures (21 CFR 820.100(a)) Training records (21 CFR 820.25(b)) and 2 more |
Recalls
| Date | Class | Recall | Product and reason |
|---|---|---|---|
| Oct 23, 2026 | Class II | V-0011-2027 | UNIPRIM Powder for Horses, (trimethoprim and sulfadiazine), Net Contents: 400 grams… and 1 more product Defective container closure. |
| Jan 28, 2026 | Class I | V-0105-2026 | HYCOAT, Hyaluronate Sodium Sterile Solution, 50mg/10mL vial, 6 x 10mL Vials per carton… and 1 more product Microbial contamination of a sterile product. |
| Aug 2, 2018 | Class III | Z-0283-2019 | Palcam Agar Base, Acumedia, PN 7669, Product Usage - Dehydrated culture media used with… Expiration date on the label is incorrect. Correct expiration date was November 30, 2020 and label on distributed product listed the… |
| Aug 2, 2018 | Class III | Z-0284-2019 | Campylobacter Blood Free Selective Medium, PN 7527A
Used with cefoperazone for the… The product is labeled with an incorrect expiration date. |
| Sep 25, 2016 | Class III | Z-2221-2017 | Urea Base Agar, Acumedia PN 7226
Urea Agar Base is used with agar for the differentiation… Storage temperature listed on the label was incorrect. Label stated 2-30¿C. Actual storage temperature is 2-8¿C. |
| Aug 8, 2016 | Class III | Z-2212-2017 | Sabouraud Dextrose Agar w /Lecithin and Tween 20
Acumedia PN 91081
Product… Storage temperature listed on the label was incorrect. Label stated 2-30¿C. Actual storage temperature is 2-8¿C. |
| Apr 22, 2016 | Class II | Z-1093-2017 | Tryptic Soy Agar, Acumedia PN 7100
500g, 2Kg, 10Kg, and 50Kg sizes light precipitate may form in prepared plates of Acumedia Tryptic Soy Agar (7100) Lot# 108166. While there is no change in growth… |
| Mar 23, 2016 | Class III | Z-2213-2017 | Nutrient Gelatin, Acumedia Part Number 7471 A
Product Usage:
Nutrient Gelatin is used… Incorrect expiration date was listed on the label. Correct expiration date was November 30, 2016. Product was labeled with expiration date… |
| Nov 30, 2015 | Class II | Z-2584-2017 | Palcam Supplement Acumedia PN 7987
Product Usage: PALCAM Supplement is used with… Contamination of product with possible Bacillus spp |
| Sep 11, 2015 | Class III | Z-2214-2017 | Beef Extract Powder, Acumedia PN 7228
Product Usage:
Beef Extract Powder is prepared… Incorrect expiration date on label. Correct expiration date was March 25, 2019. Product was labeled with expiration date of March 28,2019. |
FDA record score
49 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 |
|---|---|---|---|
| Warning letter, no close-out letter listed | Sep 24, 2026 | 30 x 1 | 30 |
| Class I recall V-0105-2026, this FEI as the recalling firm | Jan 28, 2026 | 15 x 1 | 15 |
| Class II recall V-0011-2027, this FEI as the recalling firm | Oct 23, 2026 | 4 x 1 | 4 |
| Inspection classified VAI | Oct 7, 2016 | 10 years or older, so it adds no points | 0 |
| Class II recall Z-1093-2017, this FEI as the recalling firm | Apr 22, 2016 | 10 years or older, so it adds no points | 0 |
| Class II recall Z-2584-2017, this FEI as the recalling firm | Nov 30, 2015 | 10 years or older, so it adds no points | 0 |
| Inspection classified VAI | Jan 9, 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
- LANSING, MI (US)
- Source
- device