Promise Pharmacy, LLC
FDA inspection history in Palm Harbor, Florida, 2018 to 2021
- 2
- Form 483s
- 1
- Close-out
Every document, by year
- Form 483
- Close-out
2018: one Form 483; 2019: one close-out letter; 2021: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2018–21Two Form 483s and one close-out letter, at Palm Harbor, Florida.
- 2018The longest 483 on file: 8 observations over 6 pages at Palm Harbor, Florida.
Cited most
Across all Promise Pharmacy observations on file
- 21 CFR 211.113Control of microbiological contamination2
- 21 CFR 211.165(a)Testing and release for distribution2
- 21 CFR 211.166(a)Stability testing1
- 21 CFR 211.192Production record review1
- 21 CFR 211.22(c)Responsibilities of quality control unit1
The complete Promise Pharmacy file.
All 3 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Palm Harbor, Florida
Two Form 483s and one close-out letter · 2018 to 2021 · 9 observations
Latest: Form 483, Sep 23, 2021 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2021-09-23 | 483 Form 483 | Palm Harbor, Florida | 1 | $99 |
| 2019-07-29 | Close-out Close-out letter | Palm Harbor, Florida | — | $99 |
| 2018-10-25 | 483 Form 483 | Palm Harbor, Florida | 8 | $99 |
Investigators on these documents
FEI number 3013207472 · most recent document Sep 23, 2021
About Promise Pharmacy, LLC
How many FDA Form 483s has Promise Pharmacy, LLC received?
FDA Intel has 2 Form 483s on file for Promise Pharmacy, LLC; the most recent is dated Sep 23, 2021.
When was Promise Pharmacy, LLC last inspected by FDA?
The most recent FDA inspection document on file for Promise Pharmacy, LLC is a Form 483 dated Sep 23, 2021, for the site in Palm Harbor, Florida.
What did FDA cite at Promise Pharmacy, LLC?
The regulations cited most in the observations on file for Promise Pharmacy, LLC are 21 CFR 211.113 (Control of microbiological contamination), 2 times; 21 CFR 211.165(a) (Testing and release for distribution), 2 times; 21 CFR 211.166(a) (Stability testing), 1 time.