Drug Depot Inc. dba APS Pharmacy
Form 483 issued June 17, 2022 · Palm Harbor, Florida
- Inspection
- Jun 6 – Jun 17, 2022
- Investigators
- Jessica M. Simpson· Martrice A. Packer· Saundrea A. Munroe
- Observations
- 5
- Pages
- 4
- FEI number
- 3010621916
In short: On June 17, 2022, FDA issued a Form 483 with 5 observations to Drug Depot Inc. dba APS Pharmacy in Palm Harbor, Florida (FEI 3010621916) after an inspection that ran Jun 6 – Jun 17, 2022. The investigators were Jessica M. Simpson, Martrice A. Packer and Saundrea A. Munroe. Most observations concern production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Observations span 1 system, led by production.
Most cited: FDCA 501(a)(2)(A) (3×) · 211.113 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01FDCA 501(a)(2)(A)
The ISO 5 classified aseptic processing areas had difficult to clean, paii icle-generating and visibly…
- 02FDCA 501(a)(2)(A)
Personnel conducted aseptic manipulations in an area that blocked the movement of first pass au· around…
- 03FDCA 501(a)(2)(A)
Personnel moved rapidly in the vicinity of open sterile units and instmments, which dismpted the airflow…
- 04
Your firm failed to perform adequate smoke studies under dynamic conditions to demonstrate unidirectional airflow within…
This inspection in context
Jessica M. Simpson
4 documents · 2022–2023
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Florida.
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 211.113
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 5 observations on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Drug Depot Inc. dba APS Pharmacy?
Jessica M. Simpson, Martrice A. Packer and Saundrea A. Munroe are named on this Form 483, for the inspection of Jun 6 – Jun 17, 2022. Each investigator has a profile showing what they cite most.
When was Drug Depot Inc. dba APS Pharmacy inspected by FDA?
The inspection ran Jun 6 – Jun 17, 2022, and the Form 483 is dated June 17, 2022.
How do I get the full Form 483 for Drug Depot Inc. dba APS Pharmacy?
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.