American Specialty Pharmacy, Inc. dba ASP Cares
Form 483 issued March 2, 2017 · San Antonio, Texas
- Inspection
- Feb 21 – Mar 2, 2017
- Investigator
- Jason R. Caballero
- Observations
- 2
- Pages
- 2
- FEI number
- 3012174424
In short: On March 2, 2017, FDA issued a Form 483 with 2 observations to American Specialty Pharmacy, Inc. dba ASP Cares in San Antonio, Texas (FEI 3012174424) after an inspection that ran Feb 21 – Mar 2, 2017. The investigator was Jason R. Caballero. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Observations span 1 system, led by facilities & equipment.
Most cited: 21 CFR 211.42(a) (1×) · FDCA 503B(a)(10) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Buildings used in the manufacture, processing, packing, or holding of a drug product do not have…
- 02FDCA 503B(a)(10)
Observation 2: scanned text, readable in the full document.
This inspection in context
Jason R. Caballero
26 documents · 2014–2020
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Texas.
The firmAmerican Specialty Pharmacy, Inc. dba ASP Cares history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.42(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at American Specialty Pharmacy, Inc. dba ASP Cares?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment. 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 American Specialty Pharmacy, Inc. dba ASP Cares?
Jason R. Caballero is named on this Form 483, for the inspection of Feb 21 – Mar 2, 2017. Each investigator has a profile showing what they cite most.
When was American Specialty Pharmacy, Inc. dba ASP Cares inspected by FDA?
The inspection ran Feb 21 – Mar 2, 2017, and the Form 483 is dated March 2, 2017.
How do I get the full Form 483 for American Specialty Pharmacy, Inc. dba ASP Cares?
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