Randol Mill Pharmacy
FDA inspection history across 2 sites, 2019 to 2022
- 2
- Close-outs
- 1
- Form 483
Every document, by year
- Close-out
- Form 483
2019: one Form 483; 2020: one close-out letter; 2022: one close-out letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2019–22Two close-out letters and one Form 483, at Arlington, Texas and Texas.
Cited most
Across all Randol Mill Pharmacy observations on file
- FDCA 501(a)(2)(A)Insanitary conditions4
- 21 CFR 211.111Time limitations on production1
- 21 CFR 211.113(b)Control of microbiological contamination1
- 21 CFR 211.166(a)Stability testing1
The complete Randol Mill 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
Arlington, Texas
One close-out letter and one Form 483 · 2019 to 2020 · 7 observations
Latest: Close-out, Sep 17, 2020 →Texas
One close-out letter · 2022
Latest: Close-out, Sep 28, 2022 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-09-28 | Close-out Close-out letter | Texas | — | $99 |
| 2020-09-17 | Close-out Close-out letter | Arlington, Texas | — | $99 |
| 2019-08-06 | 483 Form 483 | Arlington, Texas | 7 | $99 |
Investigators on these documents
FEI number 3010177428 · most recent document Sep 28, 2022
About Randol Mill Pharmacy
How many FDA Form 483s has Randol Mill Pharmacy received?
FDA Intel has 1 Form 483 on file for Randol Mill Pharmacy; the most recent is dated Aug 6, 2019.
When was Randol Mill Pharmacy last inspected by FDA?
The most recent FDA inspection document on file for Randol Mill Pharmacy is a Form 483 dated Aug 6, 2019, for the site in Arlington, Texas.
What did FDA cite at Randol Mill Pharmacy?
The regulations cited most in the observations on file for Randol Mill Pharmacy are FDCA 501(a)(2)(A) (Insanitary conditions), 4 times; 21 CFR 211.111 (Time limitations on production), 1 time; 21 CFR 211.113(b) (Control of microbiological contamination), 1 time.