FDA Inspection 1178420 — Bayer HealthCare, LLC
The FDA completed an inspection of Bayer HealthCare, LLC on August 26, 2022 in Berkeley, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 26, 2022
- Fiscal Year
- 2022
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Berkeley, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1162 | 21 CFR 211.28(a) | Protective Apparel Not Worn |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 3572 | 21 CFR 211.100(b) | Procedure Deviations Recorded and Justified |