Analytical Food Laboratories Inc
Form 483 issued May 17, 2024 · Grand Prairie, Texas
- Inspection
- May 7 – May 17, 2024
- Investigators
- Margaret M. Annes· Oluwasefunmi Agbanigo· Samantha E. Cleek
- Observations
- 7
- Pages
- 9
- FEI number
- 3005057567
In short: On May 17, 2024, FDA issued a Form 483 with 7 observations to Analytical Food Laboratories Inc in Grand Prairie, Texas (FEI 3005057567) after an inspection that ran May 7 – May 17, 2024. The investigators were Margaret M. Annes, Oluwasefunmi Agbanigo and Samantha E. Cleek. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.160 (general requirements).
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
The responsibilities and procedures applicable to the quality control unit are not in…
- 02
The accuracy, sensitivity, specificity and reproducibility of test methods have not…
- 03
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards, sampling plans…
- 04
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
This inspection in context
Margaret M. Annes
60 documents · 2007–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Texas.
The firmAnalytical Food Laboratories Inc history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.22(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Analytical Food Laboratories Inc?
FDA listed 7 observations on this Form 483, mostly about laboratory controls and quality system. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Analytical Food Laboratories Inc?
Margaret M. Annes, Oluwasefunmi Agbanigo and Samantha E. Cleek are named on this Form 483, for the inspection of May 7 – May 17, 2024. Each investigator has a profile showing what they cite most.
When was Analytical Food Laboratories Inc inspected by FDA?
The inspection ran May 7 – May 17, 2024, and the Form 483 is dated May 17, 2024.
How do I get the full Form 483 for Analytical Food 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.