FDA-Inspected Sites
FDA Facility Lookup
Every FDA-inspected facility on record, with its inspection history, the Form 483s it received, and the citations that keep coming back.
6,103
Investigators
232,103
Sites
148,507
Form 483s
88,971
Observations
Simtra US LLC
34
Inspections
17
Form 483s
8
EIRs
34 FDA inspections are on record for Simtra US LLC in Bloomington, United States.
View siteWoodstock Sterile Solutions Inc
29
Inspections
9
Form 483s
5
EIRs
29 FDA inspections are on record for Woodstock Sterile Solutions Inc in Woodstock, United States.
View siteWyeth BioPharma Division of Wyeth Pharmaceuticals LLC
28
Inspections
13
Form 483s
2
EIRs
28 FDA inspections are on record for Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC in Andover, United States.
View siteActavis Elizabeth LLC
27
Inspections
11
Form 483s
2
EIRs
27 FDA inspections are on record for Actavis Elizabeth LLC in Elizabeth, United States.
View sitePCI San Diego, Inc.
22
Inspections
18
Form 483s
8
EIRs
22 FDA inspections are on record for PCI San Diego, Inc. in San Diego, United States.
View siteSparhawk Laboratories, Inc.
22
Inspections
13
Form 483s
0
EIRs
22 FDA inspections are on record for Sparhawk Laboratories, Inc. in Lenexa, United States.
View siteConcordia Imaging Center
21
Inspections
0
Form 483s
0
EIRs
21 FDA inspections are on record for Concordia Imaging Center in Ponce, United States.
View siteFenwal International, Inc.
19
Inspections
12
Form 483s
1
EIRs
19 FDA inspections are on record for Fenwal International, Inc. in Maricao, United States.
View siteBTDI JV, LLP dba Touchstone Imaging Hurst
19
Inspections
0
Form 483s
0
EIRs
19 FDA inspections are on record for BTDI JV, LLP dba Touchstone Imaging Hurst in Hurst, United States.
View siteCentro Radiologico Sonografico de Cidra
18
Inspections
0
Form 483s
0
EIRs
18 FDA inspections are on record for Centro Radiologico Sonografico de Cidra in Cidra, United States.
View sitePatheon Italia S.p.A.
18
Inspections
11
Form 483s
4
EIRs
18 FDA inspections are on record for Patheon Italia S.p.A. in Monza, Italy.
View siteJFK Advanced Medical Imaging of Toms River
18
Inspections
0
Form 483s
0
EIRs
18 FDA inspections are on record for JFK Advanced Medical Imaging of Toms River in Toms River, United States.
View siteBTDI JV, LLP dba Touchstone Imaging- Mesquite
18
Inspections
0
Form 483s
0
EIRs
18 FDA inspections are on record for BTDI JV, LLP dba Touchstone Imaging- Mesquite in Mesquite, United States.
View siteVega Baja Imaging PSC/dba/Centro Radiologico Vega Baja
18
Inspections
0
Form 483s
0
EIRs
18 FDA inspections are on record for Vega Baja Imaging PSC/dba/Centro Radiologico Vega Baja in Vega Baja, United States.
View siteCardiovascular Radiology Institute
18
Inspections
0
Form 483s
0
EIRs
18 FDA inspections are on record for Cardiovascular Radiology Institute in Santurce, United States.
View siteApotex Inc.
17
Inspections
7
Form 483s
1
EIRs
17 FDA inspections are on record for Apotex Inc. in Richmond Hill, Canada.
View siteAlfred Louie Inc
17
Inspections
9
Form 483s
0
EIRs
17 FDA inspections are on record for Alfred Louie Inc in Bakersfield, United States.
View siteCentro Radiologico Clinica Yaguez, Inc.
17
Inspections
0
Form 483s
0
EIRs
17 FDA inspections are on record for Centro Radiologico Clinica Yaguez, Inc. in Mayaguez, United States.
View siteCentro Radiologico Rolon
17
Inspections
0
Form 483s
0
EIRs
17 FDA inspections are on record for Centro Radiologico Rolon in Camuy, United States.
View siteGMC Legacy LLC
17
Inspections
1
Form 483s
0
EIRs
17 FDA inspections are on record for GMC Legacy LLC in Goldsboro, United States.
View sitePAI Holdings LLC
17
Inspections
7
Form 483s
0
EIRs
17 FDA inspections are on record for PAI Holdings LLC in Greenville, United States.
View siteBrim Healthcare of Texas LLC dba Wadley Regional Medical Ctr
17
Inspections
0
Form 483s
0
EIRs
17 FDA inspections are on record for Brim Healthcare of Texas LLC dba Wadley Regional Medical Ctr in Texarkana, United States.
View siteCilag AG
16
Inspections
9
Form 483s
0
EIRs
16 FDA inspections are on record for Cilag AG in Schaffhausen, Switzerland.
View siteCondado X-Ray & Ultrasound
16
Inspections
0
Form 483s
0
EIRs
16 FDA inspections are on record for Condado X-Ray & Ultrasound in Caguas, United States.
View siteFAQ
Questions about FDA inspection history
Checking a facility or supplier, reading its outcomes, and comparing sites.
How do I find a company's USFDA inspection history?
Search the company name or city above. Each facility page lists every FDA inspection on record with its outcome (Form 483, warning letter, or clean), the Form 483s it received, the investigators who inspected it, and its recurring citations, for sites in the United States, India, China, and Europe. The Form 483 issued to Oxalis Labs in Solan in April 2026 is one recent Indian example.
What do NAI, VAI, and OAI mean on an FDA inspection?
They are FDA's inspection classifications. NAI means no action indicated. VAI means voluntary action indicated: objectionable conditions were found, but FDA is not taking regulatory action. OAI means official action indicated, the classification that can lead to a warning letter or, for a foreign facility, an import alert. Use the Last outcome filter above to narrow the directory by classification.
How can I check a supplier's FDA compliance status?
Look up the supplier's facility and check three things: the outcome of its last inspection, whether its recurring citations keep coming back, and how long ago FDA last inspected it. A warning letter or a citation that repeats across inspections is the signal to dig deeper. Atlas can also alert you when a supplier receives a new 483.
Does a Form 483 mean a facility failed its inspection?
No. A Form 483 records conditions an investigator observed; it is not a final finding. Many facilities receive a 483, respond, and see no regulatory action. What matters more is whether the same citations repeat and whether an inspection escalated to a warning letter, as at Fresenius Kabi's plant in Grand Island, Nebraska, where every inspection's outcome is listed.
How do I compare two suppliers' FDA records?
Open each supplier's facility page and compare the same four things: how many inspections are on record, how many ended in a Form 483, any warning letters, and the recurring citations. A site that repeats the same regulation across inspections carries more risk than one with a single isolated finding. Book a demo to benchmark suppliers against your own peer groups.
Supplier monitoring
Track a supplier's FDA record without checking by hand
Every inspection, Form 483, and warning letter for the facilities you depend on, with alerts when something new lands.
- Alerts on new 483s for the sites you follow
- Whether recurring citations get closed out or repeat
- Warning letters and recalls tied to the company behind each site