Drug Depot Inc. dba APS Pharmacy
Form 483 issued July 13, 2018 · Palm Harbor, Florida
- Inspection
- Jul 9 – Jul 13, 2018
- Investigator
- Seneca Toms
- Observations
- 3
- Pages
- 1
- FEI number
- 3010621916
In short: On July 13, 2018, FDA issued a Form 483 with 3 observations to Drug Depot Inc. dba APS Pharmacy in Palm Harbor, Florida (FEI 3010621916) after an inspection that ran Jul 9 – Jul 13, 2018. The investigator was Seneca Toms. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
2 of 3 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.42 (2×) · 211.113 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Personnel were observed conducting aseptic manipulations that blocked the movement of first pass air around an…
- 02
The ISO-classified area has difficult to clean, particle-generating, or visibly…
- 03
Hazardous drugs were produced without providing adequate containment, segregation, and/or cleaning of work smfaces, utensils, and/or…
This inspection in context
Seneca Toms
17 documents · 2013–2025
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in North Carolina.
The firmDrug Depot Inc. dba APS Pharmacy history
All 7 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Drug Depot Inc. dba APS Pharmacy?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment and production. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Drug Depot Inc. dba APS Pharmacy?
Seneca Toms is named on this Form 483, for the inspection of Jul 9 – Jul 13, 2018. Each investigator has a profile showing what they cite most.
When was Drug Depot Inc. dba APS Pharmacy inspected by FDA?
The inspection ran Jul 9 – Jul 13, 2018, and the Form 483 is dated July 13, 2018.
How do I get the full Form 483 for Drug Depot Inc. dba APS Pharmacy?
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