FDA Inspection
Ferndale Laboratories, Inc.Ferndale Laboratories, Inc. – FDA Inspection, Aug 26, 2009
Record Details
This FDA Inspection record concerns Ferndale Laboratories, Inc., with an inspection on August 26, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Ferndale Laboratories, Inc.
- Inspection Date
- August 26, 2009
- Product Type
- Drugs
View Company Profile
ID · c2ce1784-939f-455d-893c-572dae69c083
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 609003
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
6- 21 CFR 211.198(b)(2)Complaint Investigation/Follow-Up Findings
- 21 CFR 211.198(b)(1)Complaint Record required information
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 314.80(c)(2)Failure to report non-alert ADEs
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 314.80(b)Failure to develop written procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Ferndale Laboratories, Inc.
11| Date | Classification | Office | Project area |
|---|---|---|---|
| May 20, 2026 | Not classified | Detroit District Office | |
| February 27, 2026 | Not classified | Detroit District Office | |
| March 4, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 2, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 3, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Ferndale Laboratories, Inc.
- FDA Inspection 1317968 - 2026-05-20
- FDA Inspection 1300752 - 2026-02-27
- FDA Inspection 1163686 - 2022-03-04
- FDA Inspection 1024384 - 2017-08-02
- FDA Inspection 1005288 - 2017-02-03
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