Drug Depot Inc. dba APS Pharmacy
Form 483 issued January 22, 2016 · Palm Harbor, Florida
- Inspection
- Dec 15, 2015 – Jan 22, 2016
- Investigators
- Jennifer Lalama· Michael H. Tollon
- Observations
- 9
- Pages
- 6
- FEI number
- 3010621916
In short: On January 22, 2016, FDA issued a Form 483 with 9 observations to Drug Depot Inc. dba APS Pharmacy in Palm Harbor, Florida (FEI 3010621916) after an inspection that ran Dec 15, 2015 – Jan 22, 2016. The investigators were Jennifer Lalama and Michael H. Tollon. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Observations span 4 systems, led by production.
Most cited: 21 CFR 211.113 (2×) · 211.42 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
- 03
Aseptic processing areas are deficient regarding the system…
- 04
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
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 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 9 observations on this Form 483, mostly about production, facilities & equipment and materials. 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?
Jennifer Lalama and Michael H. Tollon are named on this Form 483, for the inspection of Dec 15, 2015 – Jan 22, 2016. Each investigator has a profile showing what they cite most.
When was Drug Depot Inc. dba APS Pharmacy inspected by FDA?
The inspection ran Dec 15, 2015 – Jan 22, 2016, and the Form 483 is dated January 22, 2016.
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.