Oakdell Pharmacy, Inc.
Form 483 issued March 1, 2013 · San Antonio, Texas
- Inspection
- Feb 25, 2013
- Investigators
- Christopher D. Leach· Lucas B. Leake
- Observations
- 7
- Pages
- 4
- FEI number
- 3004497213
In short: On March 1, 2013, FDA issued a Form 483 with 7 observations to Oakdell Pharmacy, Inc. in San Antonio, Texas (FEI 3004497213) after an inspection that ran Feb 25, 2013. The investigators were Christopher D. Leach and Lucas B. Leake. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Production and facilities & equipment account for 6 of 7 observations.
Most cited: 21 CFR 211.113(b) (2×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
- 02
Clothing of personnel engaged in the processing of drug products is not appropriate for…
- 03
Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to aseptic…
- 04
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
This inspection in context
Christopher D. Leach
11 documents · 2013–2018
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Illinois.
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(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Oakdell Pharmacy, Inc.?
FDA listed 7 observations on this Form 483, mostly about production, facilities & equipment and laboratory controls. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Oakdell Pharmacy, Inc.?
Christopher D. Leach and Lucas B. Leake are named on this Form 483, for the inspection of Feb 25, 2013. Each investigator has a profile showing what they cite most.
When was Oakdell Pharmacy, Inc. inspected by FDA?
The inspection ran Feb 25, 2013, and the Form 483 is dated March 1, 2013.
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.