Drug Depot Inc. dba APS Pharmacy
FDA inspection history across 2 sites, 2016 to 2023
- 3
- Form 483s
- 2
- Warning letters
- 2
- Close-outs
Every document, by year
- Warning letter
- Form 483
- Close-out
2016: one warning letter and one Form 483; 2018: one Form 483; 2019: one close-out letter; 2022: one Form 483; 2023: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2016–19Two Form 483s, one warning letter and one close-out letter, at Palm Harbor, Florida.
- 2016The longest 483 on file: 9 observations over 6 pages at Palm Harbor, Florida.
- 2022–23One Form 483 and one warning letter, at Palm Harbor, Florida and Lakewood, Colorado.
Cited most
Across all Drug Depot Inc. dba APS Pharmacy observations on file
- 21 CFR 211.113Control of microbiological contamination5
- 21 CFR 211.42Design and construction features4
- FDCA 501(a)(2)(A)Insanitary conditions3
- 21 CFR 211.137Expiration dating1
- 21 CFR 211.167Special testing requirements1
The complete Drug Depot Inc. dba APS Pharmacy file.
All 7 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
15% off buying them one by one
Sites
Palm Harbor, Florida
Three Form 483s, one close-out letter and one warning letter · 2016 to 2022 · 17 observations
Latest: Form 483, Jun 17, 2022 →Lakewood, Colorado
One warning letter and one close-out letter · 2023
Latest: Warning letter, Mar 31, 2023 →
Documents
7 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-03-31 | Warning letter Warning letter | Lakewood, Colorado | — | $99 |
| 2022-06-17 | 483 Form 483 | Palm Harbor, Florida | 5 | $99 |
| 2019-09-20 | Close-out Close-out letter | Palm Harbor, Florida | — | $99 |
| 2018-07-13 | 483 Form 483 | Palm Harbor, Florida | 3 | $99 |
| 2016-12-15 | Warning letter Warning letter | Palm Harbor, Florida | — | $99 |
| 2016-01-22 | 483 Form 483 | Palm Harbor, Florida | 9 | $99 |
| Undated | Close-out Close-out letter | Lakewood, Colorado | — | $99 |
Investigators on these documents
Jennifer Lalama (1)Jessica M. Simpson (1)Martrice A. Packer (1)Michael H. Tollon (1)Saundrea A. Munroe (1)Seneca Toms (1)
FEI number 3010621916 · most recent document Mar 31, 2023
About Drug Depot Inc. dba APS Pharmacy
How many FDA Form 483s has Drug Depot Inc. dba APS Pharmacy received?
FDA Intel has 3 Form 483s on file for Drug Depot Inc. dba APS Pharmacy; the most recent is dated Jun 17, 2022.
When was Drug Depot Inc. dba APS Pharmacy last inspected by FDA?
The most recent FDA inspection document on file for Drug Depot Inc. dba APS Pharmacy is a Form 483 dated Jun 17, 2022, for the site in Palm Harbor, Florida.
What did FDA cite at Drug Depot Inc. dba APS Pharmacy?
The regulations cited most in the observations on file for Drug Depot Inc. dba APS Pharmacy are 21 CFR 211.113 (Control of microbiological contamination), 5 times; 21 CFR 211.42 (Design and construction features), 4 times; FDCA 501(a)(2)(A) (Insanitary conditions), 3 times.
Has Drug Depot Inc. dba APS Pharmacy received an FDA warning letter?
Yes. FDA Intel has 2 FDA warning letters on file for Drug Depot Inc. dba APS Pharmacy; the most recent is dated Mar 31, 2023.