Custom Meds Inc.
Form 483 issued April 19, 2016 · Inverness, Florida
- Inspection
- Mar 22 – Mar 25, 2016
- Investigator
- Jennifer Lalama
- Observations
- 3
- Pages
- 2
- FEI number
- 3012161781
In short: On April 19, 2016, FDA issued a Form 483 with 3 observations to Custom Meds Inc. in Inverness, Florida (FEI 3012161781) after an inspection that ran Mar 22 – Mar 25, 2016. The investigator was Jennifer Lalama. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.165 (testing and release for distribution).
At a glance
3 of 3 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.165 (2×) · 211.160 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 02
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications designed to assure…
- 03
Each·batch of drug product required to be.. free of objectionable microorganisms is not tested through…
This inspection in context
Jennifer Lalama
31 documents · 2015–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Florida.
The firmCustom Meds Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.165
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Custom Meds Inc.?
FDA listed 3 observations on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.165 (testing and release for distribution). The opening words of each observation are shown on this page.
Who inspected Custom Meds Inc.?
Jennifer Lalama is named on this Form 483, for the inspection of Mar 22 – Mar 25, 2016. Each investigator has a profile showing what they cite most.
When was Custom Meds Inc. inspected by FDA?
The inspection ran Mar 22 – Mar 25, 2016, and the Form 483 is dated April 19, 2016.
How do I get the full Form 483 for Custom Meds 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.