Certified Laboratories, LLC
Form 483 issued January 7, 2025 · Burbank, California
- Inspection
- Dec 30, 2024 – Jan 7, 2025
- Investigator
- Dogbeda F. Mackenzie
- Observations
- 7
- Pages
- 8
- FEI number
- 3023651668
In short: On January 7, 2025, FDA issued a Form 483 with 7 observations to Certified Laboratories, LLC in Burbank, California (FEI 3023651668) after an inspection that ran Dec 30, 2024 – Jan 7, 2025. The investigator was Dogbeda F. Mackenzie. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.194 (laboratory records).
At a glance
Laboratory controls and quality system account for 7 of 7 observations.
What FDA observed
Preview: the opening words of each observation- 01
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 02
Laboratory records do not include a complete record of all data secured in the course of…
- 03
Verification of the suitability of the testing methods is deficient in that they are not performed…
- 04
The responsibilities and procedures applicable to the quality control unit…
This inspection in context
Dogbeda F. Mackenzie
14 documents · 2021–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in California.
The firmCertified Laboratories, LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.68(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Certified Laboratories, LLC?
FDA listed 7 observations on this Form 483, mostly about laboratory controls and quality system. The most-cited regulation is 21 CFR 211.194 (laboratory records). The opening words of each observation are shown on this page.
Who inspected Certified Laboratories, LLC?
Dogbeda F. Mackenzie is named on this Form 483, for the inspection of Dec 30, 2024 – Jan 7, 2025. Each investigator has a profile showing what they cite most.
When was Certified Laboratories, LLC inspected by FDA?
The inspection ran Dec 30, 2024 – Jan 7, 2025, and the Form 483 is dated January 7, 2025.
How do I get the full Form 483 for Certified Laboratories, LLC?
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.