FDA Intel

American CryoStem Corporation

Form 483 issued July 26, 2017 · Monmouth Junction, New Jersey

Inspection
Jul 17 – Jul 26, 2017
Investigator
Cody D. Rickman
Observations
9
Pages
4
FEI number
3008307548

In short: On July 26, 2017, FDA issued a Form 483 with 9 observations to American CryoStem Corporation in Monmouth Junction, New Jersey (FEI 3008307548) after an inspection that ran Jul 17 – Jul 26, 2017. The investigator was Cody D. Rickman. 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 6 of 9 observations.

Facilities & equipment4
Production2
Materials2
Laboratory controls1

What FDA observed

Preview: the opening words of each observation
  1. 01
    21 CFR 211.113(b)

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

  2. 02
    21 CFR 211.100(a)

    There are no written procedures for production and process controls designed to assure that the drug…

  3. 03
    21 CFR 211.42(c)(10)(iv)

    Aseptic processing areas are deficient regarding the system…

  4. 04
    21 CFR 211.84(d)(2)

    Establishment of the reliability of the component supplier's report of analyses is deficient in that the…

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

Cody D. Rickman

8 documents · 2011–2026

Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in Maryland.

The firm

American CryoStem Corporation 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 211.113(b)

See how FDA wrote the same problem up elsewhere.

Questions about this 483

What did FDA find at American CryoStem Corporation?

FDA listed 9 observations on this Form 483, mostly about facilities & equipment, production and materials. 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 CryoStem Corporation?

Cody D. Rickman is named on this Form 483, for the inspection of Jul 17 – Jul 26, 2017. Each investigator has a profile showing what they cite most.

When was American CryoStem Corporation inspected by FDA?

The inspection ran Jul 17 – Jul 26, 2017, and the Form 483 is dated July 26, 2017.

How do I get the full Form 483 for American CryoStem Corporation?

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