American Specialty Pharmacy
Form 483 issued August 5, 2015 · Dallas, Texas
- Inspection
- Jul 29 – Aug 5, 2015
- Investigators
- Santos E. Camara· Vilmary Negron Rodriguez
- Observations
- 10
- Pages
- 6
- FEI number
- 3011677351
In short: On August 5, 2015, FDA issued a Form 483 with 10 observations to American Specialty Pharmacy in Dallas, Texas (FEI 3011677351) after an inspection that ran Jul 29 – Aug 5, 2015. The investigators were Santos E. Camara and Vilmary Negron Rodriguez. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and production account for 7 of 10 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 02
Aseptic processing areas are deficient regarding the system…
- 03
Protective apparel is not worn as necessary to protect…
- 04
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
This inspection in context
Santos E. Camara
33 documents · 2015–2026
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in India.
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 10 observations on this Form 483, mostly about facilities & equipment, production and quality system. 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?
Santos E. Camara and Vilmary Negron Rodriguez are named on this Form 483, for the inspection of Jul 29 – Aug 5, 2015. Each investigator has a profile showing what they cite most.
When was American Specialty Pharmacy inspected by FDA?
The inspection ran Jul 29 – Aug 5, 2015, and the Form 483 is dated August 5, 2015.
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.