Randol Mill Pharmacy
Form 483 issued August 6, 2019 · Arlington, Texas
- Inspection
- Jul 23 – Aug 6, 2019
- Investigator
- Camerson E. Moore
- Observations
- 7
- Pages
- 4
- FEI number
- 3010177428
In short: On August 6, 2019, FDA issued a Form 483 with 7 observations to Randol Mill Pharmacy in Arlington, Texas (FEI 3010177428) after an inspection that ran Jul 23 – Aug 6, 2019. The investigator was Camerson E. Moore. Most observations concern production and laboratory controls.
At a glance
Observations span 2 systems, led by production.
Most cited: FDCA 501(a)(2)(A) (4×)
What FDA observed
Preview: the opening words of each observation- 01FDCA 501(a)(2)(A)
Personnel engaged in aseptic processing were…
- 02FDCA 501(a)(2)(A)
Non-sterilized equipment was used…
- 03FDCA 501(a)(2)(A)
Your facility design allowed the influx of poor quality air into…
- 04FDCA 501(a)(2)(A)
EMPI.OYEE(S) SIGNATURE Product s You produced hazardous dmgs without providing adequate cleaning of work surfaces and…
This inspection in context
Camerson E. Moore
48 documents · 2014–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Texas.
The firmRandol Mill Pharmacy history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Randol Mill Pharmacy?
FDA listed 7 observations on this Form 483, mostly about production and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Randol Mill Pharmacy?
Camerson E. Moore is named on this Form 483, for the inspection of Jul 23 – Aug 6, 2019. Each investigator has a profile showing what they cite most.
When was Randol Mill Pharmacy inspected by FDA?
The inspection ran Jul 23 – Aug 6, 2019, and the Form 483 is dated August 6, 2019.
How do I get the full Form 483 for Randol Mill 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.