FDA Intel

American Specialty Pharmacy

Form 483 issued December 19, 2014 · Plano, Texas

Inspection
Dec 9 – Dec 19, 2014
Investigators
Lisa R. Jennings· Lucas B. Leake
Observations
9
Pages
6
FEI number
3010984686

In short: On December 19, 2014, FDA issued a Form 483 with 9 observations to American Specialty Pharmacy in Plano, Texas (FEI 3010984686) after an inspection that ran Dec 9 – Dec 19, 2014. The investigators were Lisa R. Jennings and Lucas B. Leake. 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 6 of 9 observations.

Production3
Facilities & equipment3
Laboratory controls3

What FDA observed

Preview: the opening words of each observation
  1. 01
    21 CFR 211.28(a)

    Clothing ofpersonnel engaged in the manufacturing and processing of drug products is not appropriate for…

  2. 02
    21 CFR 211.42(c)(10)(iv)

    Aseptic processing areas are deficient regarding the system…

  3. 03
    21 CFR 211.113(b)

    Procedures designed to prevent microbiological contamination ofdrug products purporting to be sterile do not include…

  4. 04
    21 CFR 211.42(c)(10)(v)

    Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…

5 more observations

Plus the full detail behind each one, exactly as FDA wrote it.

Get the full 483

This inspection in context

The investigator

Lisa R. Jennings

7 documents · 2014–2016

Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Texas.

The firm

American Specialty Pharmacy history

All 2 documents on file for this site, in date order, with what was cited at each inspection.

Similar 483s

Other sites cited under 211.28(a)

See how FDA wrote the same problem up elsewhere.

Questions about this 483

What did FDA find at American Specialty Pharmacy?

FDA listed 9 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 American Specialty Pharmacy?

Lisa R. Jennings and Lucas B. Leake are named on this Form 483, for the inspection of Dec 9 – Dec 19, 2014. Each investigator has a profile showing what they cite most.

When was American Specialty Pharmacy inspected by FDA?

The inspection ran Dec 9 – Dec 19, 2014, and the Form 483 is dated December 19, 2014.

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.

$99Get it free