Ferndale Laboratories, Inc.
Form 483 issued March 4, 2022 · Ferndale, Michigan
- Inspection
- Feb 22 – Mar 4, 2022
- Observations
- 3
- Pages
- 5
- FEI number
- 1811212
In short: On March 4, 2022, FDA issued a Form 483 with 3 observations to Ferndale Laboratories, Inc. in Ferndale, Michigan (FEI 1811212) after an inspection that ran Feb 22 – Mar 4, 2022. Most observations concern quality system and production.
At a glance
2 of 3 observations on this 483 concern quality system.
What FDA observed
Preview: the opening words of each observation- 01
The quality control unit lacks authority to fully investigate…
- 02
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 03
Procedures designed to prevent objectionable microorganisms in drug products not required to be…
This inspection in context
Questions about this 483
What did FDA find at Ferndale Laboratories, Inc.?
FDA listed 3 observations on this Form 483, mostly about quality system and production. The opening words of each observation are shown on this page.
When was Ferndale Laboratories, Inc. inspected by FDA?
The inspection ran Feb 22 – Mar 4, 2022, and the Form 483 is dated March 4, 2022.
How do I get the full Form 483 for Ferndale Laboratories, Inc.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.