American Specialty Pharmacy
Form 483 issued August 23, 2018 · San Antonio, Texas
- Inspection
- Aug 14 – Aug 23, 2018
- Investigator
- Rumany C. Penn
- Observations
- 6
- Pages
- 5
- FEI number
- 3012174424
In short: On August 23, 2018, FDA issued a Form 483 with 6 observations to American Specialty Pharmacy in San Antonio, Texas (FEI 3012174424) after an inspection that ran Aug 14 – Aug 23, 2018. The investigator was Rumany C. Penn. Most observations concern production and facilities & equipment.
At a glance
Production and facilities & equipment account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of d.iug products purporting to be sterile did not include…
- 02
Written records are not always made of investigations into unexplained discrepancies and the failure of a…
- 03
Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent contamination that…
- 04
Laboratory records do not include a statement of each method used in the testing of a…
This inspection in context
Rumany C. Penn
21 documents · 2016–2022
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in California.
The firmAmerican Specialty Pharmacy history
All 5 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 American Specialty Pharmacy?
FDA listed 6 observations on this Form 483, mostly about production, facilities & equipment and quality system. The opening words of each observation are shown on this page.
Who inspected American Specialty Pharmacy?
Rumany C. Penn is named on this Form 483, for the inspection of Aug 14 – Aug 23, 2018. Each investigator has a profile showing what they cite most.
When was American Specialty Pharmacy inspected by FDA?
The inspection ran Aug 14 – Aug 23, 2018, and the Form 483 is dated August 23, 2018.
How do I get the full Form 483 for American Specialty 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.