Jack P. Herick Inc. dba Glades Drugs
Form 483 issued December 10, 2015 · Pahokee, Florida
- Inspection
- Nov 24, 2015
- Investigator
- Joanne E. King
- Observations
- 4
- Pages
- 2
- FEI number
- 3011936057
In short: On December 10, 2015, FDA issued a Form 483 with 4 observations to Jack P. Herick Inc. dba Glades Drugs in Pahokee, Florida (FEI 3011936057) after an inspection that ran Nov 24, 2015. The investigator was Joanne E. King. Most observations concern laboratory controls and materials; the most-cited regulation is 21 CFR 211.165 (testing and release for distribution).
At a glance
3 of 4 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.165 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Each container or grouping of containers of components is not examined visually upon receipt and before…
- 02
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 03
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications designed to assure…
- 04
Each batch of drug product required to be free of objectionable microorganisms is not tested…
This inspection in context
Joanne E. King
34 documents · 2013–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Florida.
The firmJack P. Herick Inc. dba Glades Drugs history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
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 Jack P. Herick Inc. dba Glades Drugs?
FDA listed 4 observations on this Form 483, mostly about laboratory controls and materials. 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 Jack P. Herick Inc. dba Glades Drugs?
Joanne E. King is named on this Form 483, for the inspection of Nov 24, 2015. Each investigator has a profile showing what they cite most.
When was Jack P. Herick Inc. dba Glades Drugs inspected by FDA?
The inspection ran Nov 24, 2015, and the Form 483 is dated December 10, 2015.
How do I get the full Form 483 for Jack P. Herick Inc. dba Glades Drugs?
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.