Company
United StatesBayer HealthCare LLC, Myerstown, PA – FDA Inspections
Inspection records and compliance data for Bayer HealthCare LLC in Myerstown, Pennsylvania. 7 FDA inspections on record, 1 Form 483, last inspected May 22, 2026.
Company Profile
This profile covers Bayer HealthCare LLC based in Myerstown, Pennsylvania, United States.
FDA Inspection History
- FDA inspections
- 7
- OAI
- 0
- VAI
- 2
- NAI
- 5
- Form 483s
- 1
- Warning letters
- 0
First inspected June 22, 2009. Last inspected May 22, 2026.
Most cited issue areas
- Authority lacking to review records, investigate errors1 inspection
- Computer control of master formula records1 inspection
- Written procedures not established/followed1 inspection
FDA inspections (7)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 22, 2026 | NAI | Human Drugs · Drug Quality Assurance | 1308052 |
| June 7, 2023 | NAI | Human Drugs · Drug Quality Assurance | 1209567 |
| February 1, 2023 | NAI | Foods & Cosmetics · Food Composition, Standards, Labeling and Econ | 1199413 |
| August 11, 2017 | VAI | Foods & Cosmetics, Human Drugs · Drug Quality Assurance | 1021532 |
| October 18, 2013 | VAI | Foods & Cosmetics, Human Drugs · Drug Quality Assurance | 852054 |
| July 21, 2011 | NAI | Foods & Cosmetics, Human Drugs · Drug Quality Assurance | 739275 |
| June 22, 2009 | NAI | Foods & Cosmetics, Human Drugs · Food Composition, Standards, Labeling and Econ | 591232 |
FDA documents
Form 483s (1)
EIRs (1)
Other FDA documents (1)
People (5)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Bayer HealthCare LLC
FEI Number
2510692
Address
400 W Stoever Ave, Myerstown, Pennsylvania 17067, United States
Country
United States
ID: 1bf3da7f-9bbd-4d63-9a03-54f116b53d33