Ferndale Laboratories, Inc.
FDA inspection history in Ferndale, Michigan, 2004 to 2022
- 1
- Form 483
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2004: one warning letter; 2022: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2004One warning letter, at Ferndale, Michigan.
- 2022One Form 483, at Ferndale, Michigan.
Cited most
Across all Ferndale Laboratories observations on file
- 21 CFR 211.113(a)Control of microbiological contamination1
- 21 CFR 211.192Production record review1
- 21 CFR 211.22(a)Responsibilities of quality control unit1
The complete Ferndale Laboratories file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Ferndale, Michigan
One Form 483 and one warning letter · 2004 to 2022 · 3 observations
Latest: Form 483, Mar 4, 2022 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-03-04 | 483 Form 483 | Ferndale, Michigan | 3 | $99 |
| 2004-11-19 | Warning letter Warning letter | Ferndale, Michigan | — | $99 |
FEI number 1811212 · most recent document Mar 4, 2022
About Ferndale Laboratories, Inc.
How many FDA Form 483s has Ferndale Laboratories, Inc. received?
FDA Intel has 1 Form 483 on file for Ferndale Laboratories, Inc.; the most recent is dated Mar 4, 2022.
When was Ferndale Laboratories, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Ferndale Laboratories, Inc. is a Form 483 dated Mar 4, 2022, for the site in Ferndale, Michigan.
What did FDA cite at Ferndale Laboratories, Inc.?
The regulations cited most in the observations on file for Ferndale Laboratories, Inc. are 21 CFR 211.113(a) (Control of microbiological contamination), 1 time; 21 CFR 211.192 (Production record review), 1 time; 21 CFR 211.22(a) (Responsibilities of quality control unit), 1 time.
Has Ferndale Laboratories, Inc. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Ferndale Laboratories, Inc.; the most recent is dated Nov 19, 2004.