Talon Compounding Pharmacy
Form 483 issued June 29, 2016 · San Antonio, Texas
- Inspection
- Jun 21 – Jun 29, 2016
- Investigators
- Hala L. Selby· Lori G. Cantin· Patty P. Kaewussdangkul
- Observations
- 10
- Pages
- 12
- FEI number
- 3009192575
In short: On June 29, 2016, FDA issued a Form 483 with 10 observations to Talon Compounding Pharmacy in San Antonio, Texas (FEI 3009192575) after an inspection that ran Jun 21 – Jun 29, 2016. The investigators were Hala L. Selby, Lori G. Cantin and Patty P. Kaewussdangkul. 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 7 of 10 observations.
Most cited: 21 CFR 211.113(b) (2×)
What FDA observed
Preview: the opening words of each observation- 01
Aseptic processing areas are deficient regarding systems for maintaining any equipment used to…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
- 03
Clothing of personnel engaged in the processing of drug products is not appropriate for…
- 04
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the equipment…
This inspection in context
Hala L. Selby
2 documents · 2016–2025
Cites 211.42(c)(10)(iv) (design and construction features) more than any other section. Most of their documents are for sites in California.
The firmTalon Compounding Pharmacy history
All 4 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 Talon Compounding Pharmacy?
FDA listed 10 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 Talon Compounding Pharmacy?
Hala L. Selby, Lori G. Cantin and Patty P. Kaewussdangkul are named on this Form 483, for the inspection of Jun 21 – Jun 29, 2016. Each investigator has a profile showing what they cite most.
When was Talon Compounding Pharmacy inspected by FDA?
The inspection ran Jun 21 – Jun 29, 2016, and the Form 483 is dated June 29, 2016.
How do I get the full Form 483 for Talon Compounding 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.