36
Inspection reports (EIR)
What this register is, and is not
These are documents FDA has released , not a record of inspections that occurred. FDA posts a record only through proactive disclosure or the “three or more rule” (5 U.S.C. § 552(a)(2)(D)); it withholds records while a compliance action is open (21 CFR 20.64(d)), archives them after five years, and redacts portions under 21 CFR Part 20. In FDA’s own words, the absence of a facility here “should not be interpreted to mean that the facility has not been subject to appropriate regulatory oversight.” Record types are FDA’s own labels, carried through unchanged.
Search released FDA inspection documents Record type Record type: all 483 (2,500) State Referral Letter (189) FMD-145 Letter (188) 483 Response (126) Untitled Letter (77) Other Correspondence (49) Establishment Inspection Report (EIR) (36) Workplan (27) Sample Record (23) Adverse Determination Letter (21) Amended 483 (20) Warning Letter Response (18) Consent Decree (16) Consent Decree Correspondence (9) Consumer Complaint Record (9) FDA Requested Recall Letter (8) Untitled Letter Response (6) Recall Record (5) Memo (4) Investigation Memo (4) Response (1) Receipt of Payment Letter (1) Establishment type Establishment type: all Producer of Sterile Drug Products (753) Outsourcing Facility (451) Producer of Sterile and Non Sterile Drug Products (231) Manufacturer (213) Finished Pharmaceutical Manufacturer (163) Producer of Non Sterile Drug Products (133) Drug Manufacturer (122) Shell Egg Producer (81) Compounding Pharmacy (77) Active Pharmaceutical Ingredient Manufacturer (72) Medical Device Manufacturer (60) Sterile Drug Manufacturer (59) Human Drug Manufacturer (35) OTC Drug Manufacturer (33) Active Pharmaceutical Ingredient & Finished Dosage Manufacturer (33) Blood Bank (33) Farm (28) Clinical Investigator (24) Egg Manufacturer (24) American National Red Cross (20) Pharmaceutical Manufacturer (18) Contract Testing Laboratory (17) Health Care Facility (15) Medical Device and Pharmaceutical Manufacturer (14) Drug Substance Manufacturer (14) Biological Drug Manufacturer (12) Vaccine Manufacturer (10) Drug Substance Intermediate Manufacturer (10) API (animal origin) Manufacturer (10) Sponsor (10) Hospital Blood Bank (10) Pet Food Manufacturer (9) Importer/Warehouse/Repacker (9) Control Testing Laboratory (9) Institutional Review Board (8) Drug Product Manufacturer (8) Peanut Processor/Manufacturer (8) Bioanalytical Lab (8) API Manufacturer (8) Cheese Manufacturer (8) Ready-to-Eat Produce Manufacturer (7) Smoked Fish Processor (7) Drug Substance and Drug product Manufacturer (7) Reproductive Human Tissue (7) Fruit Processor (6) Finished Drug Product Manufacturer (6) Human Tissue Establishment (5) Manufacturer and Repacker (5) Licensed Biological Drug Manufacturer (5) Plasmapheresis Center (5) Peanut and Peanut Butter Manufacturer (5) Infant Formula Manufacturer (5) Peanut Butter Manufacturer (5) Sprout Grower (4) Initial Distributor, Manufacturer, Specification Developer (4) Pistachio Manufacturer (4) HCT/P Distributor (4) Human Reproductive Tissue Establishment (4) Source Plasma (4) Pharmaceutical and Medical Device Manufacturer (4) Contract Manufacturer (4) Specification Developer (4) IVD Manufacturer (4) Animal Feed Manufacturer (4) Reproductive Tissue (4) Contract Sterilizer (3) Biopharmaceutics Analytical Facility (3) CAR-T Cell Therapy Manufacturer (3) Device Manufacturer (3) Distributor (3) Donor Center (3) HCT/P Processor and Distributor (3) Homeopathic Drug Manufacturer (3) Human and Veterinary Drug Manufacturer (3) Human Tissue (3) Human Tissue Distributor (3) Manufactuer (3) Nuclear Pharmacy (3) Pet Drug Manufacturer (3) Reproductive (3) Source Plasma Collection Facility (3) Source Plasma Establishment (3) Sterile Manufacturer (3) Testing Laboratory (3) Human Tissue Processor (2) HCT/P Warehouse/Distributor (2) Good Laboratory Practices Facility (2) Therapeutic Drug Substance Manufacturer (2) Biologics & Medical Device Manufacturer (2) Sterile Pharmaceutical Manufacturer (2) Human Pharmaceutical OTC Manufacturer (2) Reproductive Establishment (2) Medical Device (2) Reproductive Firm (2) Human Reproductive Tissue (2) Sterile Drug Product Manufacturer (2) Viral Vector Testing Lab (2) Tissue Processor (2) OTC Manufacturer (2) OTC Pharmaceutical Manufacturer (2) Human Tissue and Medical Device Manufacturer (2) Dietary Supplement Manufacturer (2) Seafood Processor (2) Medical Food and OTC Drug Manufacturer (2) Dietary Supplement and Conventional Food Manufacturer (2) Contract Laboratory (2) Bakery (2) HCT/P Reproductive Establishment (2) Drug Wholesale Distributor (2) Biologics Manufacturer (2) Source Plasma Center (2) Initial Importer/ Distributor (1) Blood Donor Center (1) Blood Component Storage and Distribution Facility (1) Licensed Antigen Component Manufacturer for IVDs (1) Blood Bank and Transfusion Services (1) Licensed Biological Drug Substance Manufacturer (1) Tissue Testing Laboratory (1) Blood Bank and Donor Center (1) Manufacturer & Specification Developer (1) Manufacturer and Contract Manufacturer (1) Biotechnology Drug Manufacturer (1) Manufacturer, repacker/relabeler (1) Manufacturing (1) Medical Device and Manufactuer (1) Biotech API Manufacturer (1) Biopharmaceutics Analytical Facility & Nonclinical Laboratory (1) Medical Device Sponsor (1) Medical Food Manufacturer (Pediatric OES) (1) Medical Food, OTC Drug, and Cosmetic Manufacturer (1) Medical Gas (1) Medical Gas Manufacturer (1) Medical Gas Manufacturer and Repackager (1) Medical Gas Repacker (1) Military Blood Bank and Military Donor Center (1) Multi-commodity Ambient Warehouse (1) Non- Sterile Manufacturer (1) Nonclinical Laboratory (1) Transfusion Services/Blood Bank (1) Biologics/Viral Vector (1) Biologics Vaccine Manufacturer (1) Own Label Distributor/Repackager/Relabeler (1) Packaging and Labeling (1) Biologics Manufactuter (1) Biologics IVD Manufacturer (1) Pediatric Electrolyte Oral Solution Manufacturer (1) Transufusion Service (1) Biologics Blood Product Manufacturer (1) Biologics - Pharmaceuticals, Medical Devices (1) Pharmaceutical Packager/Distributer (1) Biological product manufacturer/distributor (1) Plasma Center (1) Plasma Derivative Manufacturer (1) Plasma Derivatives Manufacurer (1) Plasma Donor Center (1) Plasmapheresfa Center (1) Plasmapheresis (1) Biological Product Manufacturer (1) Prescription Drug Manufacturer (1) Biological Product Distributor (1) Biological Manufacturer (1) Biological Drug Substance/Product Manufacturer (1) Biological Drug Substance Manufacturer (1) Release testing facility (1) Repackager/Relabeler (1) Repacker/Relabeler (1) Vaccine Bulk Product (1) Reproductive Clinic (1) Reproductive Fertility Center (1) Reproductive HCT/P (1) Biological Drug Product Manufactuer (1) Reproductive Human Tissue Establishment (1) Biologic Manufacturer (1) Reproductive Tissue Establishment (1) Reproductive Tissue Facility (1) Biologic Drug Manufacturer (1) Smoked Fish Manufacturer (1) Software Manufacturer (1) API Manufacture (1) Source Plasma Collection Establishment (1) Aircraft Conveyance (1) Source Plasma Donation Center (1) Source Plasma Donor Center (1) Vaccine/Blood Products Manufacturer (1) Source Plasma Firm (1) Spec Developer/Manufacturer (1) API and Intermediate Manufacturer (1) API and Homeopathic Drug Product Manufacturer (1) ANDA Sponsor (1) Analytical facility (1) Sterile Drug Substance Manufacturer (1) Veterinary Compounding Pharmacy (1) Dispenser of Prescription Drugs (1) Drug Manufacturing Facility (1) Drug Product (1) Drug Product Packager, Medical Device Packager (1) Drug Repackager (1) CRO (1) Critical API Intermediate Manufacturer (1) Drug Substance/Drug Product Manufacturer (1) DS and DP Manufacturer (1) Excipient Gel Manufacturer (1) Corporate Office (1) Corporate Headquarters (1) Control Laboratory (1) Contract testing facility (1) Finished Product Drug Manufacturer (1) Contract Research Organization (1) GLP (1) HCT/P (1) Contract OTC Drug Manufacturer (1) HCT/P Establishment (1) HCT/P Manufacturer (1) HCT/P Reproductive Firm (1) HCT/P Storage & Distribution Facility (1) HCT/P Storage and Distributor (1) Contract Manufacturer & Distributor (1) Heparin Sodium Crude Manufacture (1) Hospital Blood Bank/Transfusion service (1) Hospital Blood Bank/Transfusion Services (1) Hospital Transfusion service (1) Contract Drug Manufacturer (1) Complaints File Establishment (1) Tissue Recovery Establishment (1) Complaint File Establishment/Manufacturer (1) Human Tissue Reproductive Establishment (1) Community Non Hospital Blood Bank (1) Cell and Gene Therapy (1) Bulk Drug Substance Manufacturer (1) State State: all Alabama (36) Alaska (5) Arizona (82) Arkansas (39) California (298) Colorado (71) Connecticut (36) Delaware (5) District of Columbia (23) Florida (191) Georgia (45) Guam (1) Hawaii (1) Idaho (13) Illinois (85) Indiana (71) Iowa (25) Kansas (30) Kentucky (34) Louisiana (19) Maine (10) Maryland (91) Massachusetts (60) Michigan (119) Minnesota (47) Mississippi (39) Missouri (42) Montana (18) Nebraska (19) Nevada (41) New Hampshire (14) New Jersey (117) New Mexico (13) New York (147) North Carolina (52) North Dakota (4) Ohio (88) Oklahoma (35) Oregon (25) Pennsylvania (151) Puerto Rico (7) Rhode Island (7) South Carolina (33) South Dakota (3) Tennessee (72) Texas (263) Utah (23) Vermont (5) Virginia (40) Washington (29) West Virginia (8) Wisconsin (39)
3,337 MATCHING DOCUMENTS · PAGE 1 OF 167
3,337 documents match.
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