Merissa Corp. dba Johnson Compounding and Wellness
Form 483 issued May 28, 2015 · Waltham, Massachusetts
- Inspection
- May 28, 2015
- Investigator
- Edmund F. Mrak
- Observations
- 6
- Pages
- 6
- FEI number
- 3004611372
In short: On May 28, 2015, FDA issued a Form 483 with 6 observations to Merissa Corp. dba Johnson Compounding and Wellness in Waltham, Massachusetts (FEI 3004611372) after an inspection that ran May 28, 2015. The investigator was Edmund F. Mrak. 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 5 of 6 observations.
Most cited: 21 CFR 211.42 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 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 do not include…
- 03
Aseptic processing areas are deficient regarding the system…
- 04
Each lot of a drug product container and closure that is liable to microbiological contamination that…
This inspection in context
Edmund F. Mrak
30 documents · 2010–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in New York.
The firmMerissa Corp. dba Johnson Compounding and Wellness history
The site's inspection history, in date order.
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 Merissa Corp. dba Johnson Compounding and Wellness?
FDA listed 6 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 Merissa Corp. dba Johnson Compounding and Wellness?
Edmund F. Mrak is named on this Form 483, for the inspection of May 28, 2015. Each investigator has a profile showing what they cite most.
When was Merissa Corp. dba Johnson Compounding and Wellness inspected by FDA?
The inspection ran May 28, 2015, and the Form 483 is dated May 28, 2015.
How do I get the full Form 483 for Merissa Corp. dba Johnson Compounding and Wellness?
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