FDA Intel

The Apothecary Shoppe, LLC

483 response sent April 6, 2015 · Tulsa, Oklahoma

Inspection
Mar 3 – Mar 13, 2015
Observations
10
Pages
11
FEI number
3001576820

In short: This is The Apothecary Shoppe, LLC's written response to FDA, dated April 6, 2015, for its site in Tulsa, Oklahoma (FEI 3001576820). It sets out the corrective actions the firm committed to.

At a glance

Facilities & equipment and laboratory controls account for 8 of 10 observations.

Facilities & equipment5
Laboratory controls3
Production2

Most cited: 21 CFR 211.42 (3×)

What the firm responded to

Preview: the opening words of each observation

Dashed: section inferred by FDA Intel and checked against the regulation text

  1. 01
    21 CFR 211.28

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

  2. 02
    21 CFR 211.42

    Aseptic processing areas are deficient tegarding the system…

  3. 03
    21 CFR 211.113

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

  4. 04
    21 CFR 211.42

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

6 more observations

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

Get the full response

This inspection in context

The firm

The Apothecary Shoppe, LLC history

All 5 documents on file for this site, in date order, with what was cited at each inspection.

Similar documents

Other sites cited under 211.42

See how FDA wrote the same problem up elsewhere.

Questions about this response

When was The Apothecary Shoppe, LLC inspected by FDA?

The inspection ran Mar 3 – Mar 13, 2015, and the 483 response is dated April 6, 2015.

How do I get the full 483 response for The Apothecary Shoppe, LLC?

Download the original PDF from FDA Intel for $199, with no subscription. You also get an invoice PDF with the order.

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