Oakdell Compounding Pharmacy LLC — FDA Facility Profile
Oakdell Compounding Pharmacy LLC is an FDA-inspected facility (FEI 3004497213) located in San Antonio, TX, US. RegDataLab tracks 2 FDA inspections and 2 compliance actions at this facility.
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What FDA found at this site
- Latest inspection
- Mar 1, 2013: Official Action Indicated (OAI)
- Inspections on record
- 2 (2 OAI)
- Last OAI inspection
- Mar 1, 2013
- Warning letters
- 2 listed by FDA for this FEI, latest May 27, 2014
- Form 483 and inspection documents
- 4 in FDA's reading room
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Mar 1, 2013 | Official Action Indicated (OAI) | Clothing appropriate for duties performed (21 CFR 211.28(a)) Aseptic Processing Area (21 CFR 211.42(c)(10)) Environmental Monitoring System (21 CFR 211.42(c)(10)(iv)) Cleaning System (21 CFR 211.42(c)(10)(v)) and 3 more |
| Mar 1, 2013 | Official Action Indicated (OAI) | Clothing appropriate for duties performed (21 CFR 211.28(a)) Aseptic Processing Area (21 CFR 211.42(c)(10)) Environmental Monitoring System (21 CFR 211.42(c)(10)(iv)) Cleaning System (21 CFR 211.42(c)(10)(v)) and 3 more |
Form 483s and inspection documents
- Mar 16, 2018: State Referral Letter on FDA.gov
- Mar 2, 2018: 483 on FDA.gov
- Jan 23, 2018: FMD-145 Letter on FDA.gov
- Jul 10, 2015: 483 on FDA.gov
Facility details
- Company
- Oakdell Compounding Pharmacy LLC
- Location
- San Antonio, TX (US)
- Source
- inspections