Clinical Apothecaries
Form 483 issued November 20, 2013 · Medina, Ohio
- Inspection
- Nov 6 – Nov 20, 2013
- Investigators
- Andrew J. Lang· Joshua S. Hunt
- Observations
- 8
- Pages
- 3
- FEI number
- 3005124205
In short: On November 20, 2013, FDA issued a Form 483 with 8 observations to Clinical Apothecaries in Medina, Ohio (FEI 3005124205) after an inspection that ran Nov 6 – Nov 20, 2013. The investigators were Andrew J. Lang and Joshua S. Hunt. Most observations concern laboratory controls and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Laboratory controls and production account for 5 of 8 observations.
Most cited: 21 CFR 211.42 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Clothing of personnel engaged in the processing of drug products is not appropriate for…
- 02
Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include…
- 04
Each batch of drug product required to be free of objectionable microorganisms is not tested…
This inspection in context
Andrew J. Lang
1 document · 2013
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Ohio.
The firmClinical Apothecaries history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Clinical Apothecaries?
FDA listed 8 observations on this Form 483, mostly about laboratory controls, production and facilities & equipment. 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 Clinical Apothecaries?
Andrew J. Lang and Joshua S. Hunt are named on this Form 483, for the inspection of Nov 6 – Nov 20, 2013. Each investigator has a profile showing what they cite most.
When was Clinical Apothecaries inspected by FDA?
The inspection ran Nov 6 – Nov 20, 2013, and the Form 483 is dated November 20, 2013.
How do I get the full Form 483 for Clinical Apothecaries?
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.