Genentech, Inc. FDA Inspection Record
Genentech, Inc. is an FDA-inspected facility (FEI 2917293) located in South San Francisco, CA, US. RegDataLab tracks 34 FDA inspections at this facility.
What FDA found at this site
- Latest inspection
- Aug 4, 2026: No Action Indicated (NAI)
- Inspections on record
- 34 (8 VAI, 26 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
- Form 483 and inspection documents
- 1 in FDA's reading room
- Recalls as the recalling firm
- 15, latest May 20, 2024
- Import refusals
- 10 or more
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Aug 4, 2026 | No Action Indicated (NAI) | No citations listed |
| May 15, 2026 | No Action Indicated (NAI) | No citations listed |
| Apr 7, 2026 | No Action Indicated (NAI) | No citations listed |
| Apr 21, 2025 | No Action Indicated (NAI) | No citations listed |
| May 2, 2024 | Voluntary Action Indicated (VAI) | Failure to comply with REMS Implementation System (FDCA 505-1(f)(4)) |
| Mar 20, 2024 | No Action Indicated (NAI) | No citations listed |
| Mar 12, 2024 | Voluntary Action Indicated (VAI) | IND safety report (21 CFR 312.56(c)) Records of receipt, shipment, disposition (21 CFR 312.57(a)) General responsibilities of sponsors (21 CFR 312.50) |
| Aug 11, 2023 | Voluntary Action Indicated (VAI) | Notification of FDA of termination of investigator (21 CFR 312.56(b)) |
| Feb 21, 2023 | No Action Indicated (NAI) | No citations listed |
| Oct 7, 2022 | No Action Indicated (NAI) | No citations listed |
Recalls
| Date | Class | Recall | Product and reason |
|---|---|---|---|
| May 20, 2024 | Class II | D-0509-2024 | Cathflo activase (ALTEPLASE), 2mg vials, Rx only, Genentech Inc., South San Francisco, CA… Lack of Assurance of Sterility: Deformed stoppers observed during filling operations for Cathflo Activase. |
| Oct 18, 2022 | Class III | D-0025-2023 | Susvimo (ranibizumab injection), 100mg/mL, sold together as a) carton containing One… Defective Delivery System: Commercial implants do not meet the filed specification for the intended use, a few patients have experienced an… |
| Jun 9, 2021 | Class II | D-0650-2021 | Xolair (omalizumab) Injection, 150 mg/1 mL, 1 prefilled syringe, Rx Only, For Subcutaneous… Failed Stability Specifications: Out of Specification results of Polysorbate 20 (PS20) content were detected at the 12 month testing time… |
| Apr 20, 2021 | Class III | D-0357-2021 | Evrysdi (risdiplam) for oral solution, 60 mg/80mL (0.75mg/mL), 80 mL total volume after… Defective Container: complaints received regarding some incorrect press-in-bottle-adapters (PIBA), the incorrect PIBAs have a female instead… |
| Feb 5, 2018 | Class III | D-0416-2018 | Klonopin (clonazepam) 0.5 mg Tablets,100-count bottle, Rx only. Made in Canada… Labeling: Not Elsewhere Classified: Schedule IV controlled substance indicator of CIV being omitted from the product carton, primary label… |
| Sep 5, 2017 | Class I | D-1175-2017 | Activase (alteplase), 100 mg (58 million IU), Lyophilized vial, packaged with 1… Non-Sterility:presence of cracked or chipped glass at the neck of Sterile Water for Injection vials. |
| Mar 13, 2017 | Class II | D-0648-2017 | Cotellic (cobimetinib) Tablets, 20 mg, 63 count bottle, Rx Only, Made in Switzerland… Superpotent Drug: An oversized tablet was found in a bottle. |
| Sep 27, 2012 | Class III | D-097-2013 | CellCept (mycophenolate mofetil) capsules, 250 mg, packaged in a) 12 x 120-count bottles… Short Fill: some bottles contained less than 120-count per labeled claim. |
| Sep 20, 2012 | Class II | D-087-2013 | Nutropin AQ NuSpin 20 (somatropin (rDNA origin) injection} 20 mg/ 2mL Genentech, South San… and 1 more product Miscalibrated and/or Defective Delivery System: Genentech has received complaints for Nutropin AQ NuSpin 10 & 20 reporting that the dose… |
| Jul 30, 2012 | Class I | D-135-2013 | Trastuzumab Kit containing 1 vial Trastuzumab (nominal content: 440 mg); 1 20 mL multiple… Presence of Particulate Matter: One lot of Bacteriostatic Water for Injection, USP diluent vials that were packed with Trastuzumab Kits for… |
Form 483s and inspection documents
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
- Genentech, Inc.
- Location
- South San Francisco, CA (US)
- Source
- inspections