Collection: Products
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Inspection Reports & Warning Letter – Genzyme Corporation (Framingham, MA; Inspection IDs 1176107 & 1232210; Warning Letter Case ID 690604)
Regular price $69.00 USDRegular priceUnit price / per -
Inspection Reports – Kovas Co., Ltd (Paju, Korea, FEI 3009640188; Inspections Nov 18–22, 2019 & Nov 25–29, 2024)
Regular price $69.00 USDRegular priceUnit price / per -
Inspection Reports – ProFresh International Corp. (Philadelphia, PA, 07/16/2021, FEI 3003273521); BioDelivery Sciences International, Inc. (Raleigh, NC, 05/21/2021, FEI 3013975812)
Regular price $69.00 USDRegular priceUnit price / per -
Inspection Reports – Specialty Process Labs (Phoenix, AZ, 11/04/2021, FEI 3017888878); WCCT Global, Inc. (Cypress, CA, 06/18/2021, FEI 3006237846); Qikmoov LLC (Norwalk, CA, 06/30/2021, FEI 3017721316)
Regular price $69.00 USDRegular priceUnit price / per -
Inspection Reports – Stella & Chewy’s, LLC (Oak Creek, WI, FEI 3006177750; Inspection ID 963217)
Regular price $69.00 USDRegular priceUnit price / per -
Internal Intranet Screenshots – FDA Internal Intranet Homepage & Links
Regular price $69.00 USDRegular priceUnit price / per -
Intranet Records Request – FDA Homepage, Sitemap & Linked Pages
Regular price $69.00 USDRegular priceUnit price / per -
Label Information Request – ANDA#210354
Regular price $69.00 USDRegular priceUnit price / per -
Label Request – Methylene Blue Injection (ANDA 217561, 216959, 216955)
Regular price $69.00 USDRegular priceUnit price / per -
Labeling Request – BLA 021684 Gonal‑F RFF Redi‑Ject (Follitropin Alfa/Beta, All Levels)
Regular price $69.00 USDRegular priceUnit price / per -
Labeling Request – NDA 016087 VALIUM (Diazepam, Roche)
Regular price $69.00 USDRegular priceUnit price / per -
Labels – BLA 020563 HUMALOG (Insulin Lispro Recombinant, All Strengths/Levels)
Regular price $69.00 USDRegular priceUnit price / per -
Labels – BLA 103353 Neupogen (filgrastim 300 mcg & 480 mcg, All Strengths/Concentrations)
Regular price $69.00 USDRegular priceUnit price / per -
Labels – NDA 017422 BICNU (Carmustine 100mg/vial, All Levels for RLD Comparison)
Regular price $69.00 USDRegular priceUnit price / per -
Labels – Reference Product ANDA 076512 (Cytarabine 100 mg/mL) Evaluation
Regular price $69.00 USDRegular priceUnit price / per -
Last Approved Labeling – NDA 019443 (Sodium Bicarbonate in Plastic Container, Abbott)
Regular price $69.00 USDRegular priceUnit price / per -
Listeria Outbreak - Dole Salad Mixes (January 1, 2015–2024)
Regular price $69.00 USDRegular priceUnit price / per -
Lithium-Ion Battery Safety Records – MXJO 18650 Explosions/Fires
Regular price $69.00 USDRegular priceUnit price / per -
MDIC-FDA Workshop Participants – Feb 3, 2020 (Advancing EUA IVD Products)
Regular price $69.00 USDRegular priceUnit price / per -
Medical Device Reports – Medtronic HeartWare HVAD (PMA P100047)
Regular price $69.00 USDRegular priceUnit price / per -
Microsoft Excel List – SE Market Orders (11/29/23 – 4/9/24)
Regular price $69.00 USDRegular priceUnit price / per -
Multiple 510(k)s – DEN210046, K152954, K140586, K223797
Regular price $69.00 USDRegular priceUnit price / per -
NADA Request – Original NADA 113-645 for Cloprostenol (Estrumate)
Regular price $69.00 USDRegular priceUnit price / per -
National Shellfish Sanitation Program (NSSP) - Buzzards Bay Information
Regular price $69.00 USDRegular priceUnit price / per -
NDA 021924 Request – TIROSINT (Levothyroxine Sodium, Chemistry & Bioequivalence Reviews)
Regular price $69.00 USDRegular priceUnit price / per -
NDA 208232 Orphan Drug Designation Letter for Mycapssa (6/17/10)
Regular price $9.95 USDRegular priceUnit price / per -
New Culture GRAS Notice Disclosable Portions (2022-2024)
Regular price $69.00 USDRegular priceUnit price / per -
Non-Nutritive Sweeteners in Canned Fruits - FDA Documents & Labeling Opinions
Regular price $69.00 USDRegular priceUnit price / per -
NOOPEPT Request – NDA, Import Alerts & Correspondence
Regular price $69.00 USDRegular priceUnit price / per -
Northgate Gonzalez, LLC Identified as Consignee, Importer, or FSVP Importer
Regular price $69.00 USDRegular priceUnit price / per -
Notices of Action for Ultra Defense Sani Smart Hand Sanitizer
Regular price $69.00 USDRegular priceUnit price / per -
Notices of Action for Ultra Defense Sani Smart Hand Sanitizers
Regular price $69.00 USDRegular priceUnit price / per -
Packaging Insert & Labeling Request – Octreotide Acetate Injectable (ANDA‑210317, TEVA PHARMS USA INC)
Regular price $69.00 USDRegular priceUnit price / per -
Packaging Insert & Labeling – Phytonadione Injection (1mg/0.5 mL, ANDA 214966, CIPLA LTD)
Regular price $69.00 USDRegular priceUnit price / per -
Pediatric Written Request – CDER to Pharmacia & Upjohn (Minoxidil, NDA 018154, Nov 8, 2000)
Regular price $69.00 USDRegular priceUnit price / per -
Performance Plan – AeroChamber Plus Flow-Vu (K181649)
Regular price $69.00 USDRegular priceUnit price / per