FDA Inspection 1163686 — Ferndale Laboratories, Inc.
The FDA completed an inspection of Ferndale Laboratories, Inc. on March 4, 2022 in Ferndale, MI. 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
- March 4, 2022
- Fiscal Year
- 2022
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Ferndale, MI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1033 | 21 CFR 211.22(a) | Authority lacking to review records, investigate errors |
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |