Oakdell Pharmacy, Inc.
Form 483 issued March 29, 2017 · San Antonio, Texas
- Inspection
- Mar 20 – Mar 29, 2017
- Investigator
- Stephen D. Brown
- Observations
- 2
- Pages
- 2
- FEI number
- 3004497213
In short: On March 29, 2017, FDA issued a Form 483 with 2 observations to Oakdell Pharmacy, Inc. in San Antonio, Texas (FEI 3004497213) after an inspection that ran Mar 20 – Mar 29, 2017. The investigator was Stephen D. Brown. Most observations concern production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
2 of 2 observations on this 483 concern production.
Most cited: 21 CFR 211.113 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Disinfecting agents and wipes used in the ISO S aseptic processing…
- 02
Media fills were not performed that closely simulate aseptic production operations incorporating, as appropriate, worst-case activities…
This inspection in context
Stephen D. Brown
42 documents · 2006–2021
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Texas.
The firmOakdell Pharmacy, Inc. history
All 2 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 Oakdell Pharmacy, Inc.?
FDA listed 2 observations on this Form 483, mostly about production. 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 Oakdell Pharmacy, Inc.?
Stephen D. Brown is named on this Form 483, for the inspection of Mar 20 – Mar 29, 2017. Each investigator has a profile showing what they cite most.
When was Oakdell Pharmacy, Inc. inspected by FDA?
The inspection ran Mar 20 – Mar 29, 2017, and the Form 483 is dated March 29, 2017.
How do I get the full Form 483 for Oakdell Pharmacy, Inc.?
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.