Pharmacy Creations
Form 483 issued July 10, 2017 · Ledgewood, New Jersey
- Inspection
- Jun 1 – Jun 2, 2017
- Investigator
- Jose M. Cayuela
- Observations
- 1
- Pages
- 1
- FEI number
- 3003348498
In short: On July 10, 2017, FDA issued a Form 483 with 1 observation to Pharmacy Creations in Ledgewood, New Jersey (FEI 3003348498) after an inspection that ran Jun 1 – Jun 2, 2017. The investigator was Jose M. Cayuela. Most observations concern production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
1 of 1 observations on this 483 concern production.
Most cited: 21 CFR 211.113 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The ISO 5 laminar air flow hood was not…
This inspection in context
Jose M. Cayuela
23 documents · 2012–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmPharmacy Creations history
All 7 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Pharmacy Creations?
FDA listed 1 observation on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Pharmacy Creations?
Jose M. Cayuela is named on this Form 483, for the inspection of Jun 1 – Jun 2, 2017. Each investigator has a profile showing what they cite most.
When was Pharmacy Creations inspected by FDA?
The inspection ran Jun 1 – Jun 2, 2017, and the Form 483 is dated July 10, 2017.
How do I get the full Form 483 for Pharmacy Creations?
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.